FDA 510(k) Applications for Medical Device Product Code "LCP"
(Assay, Glycosylated Hemoglobin)

FDA 510(k) Number Applicant Device Name Decision Date
K991246 A.P. TOTAL CARE, INC. FRUCTOSAMINE, MODEL FR 106-01 12/16/1999
K791642 ABBOTT LABORATORIES A-GENT GLYCOSPEC 10/17/1979
K832775 ABBOTT LABORATORIES A-GENT GLYCOSYLATED HEMOGLOBIN 09/29/1983
K991483 ABBOTT LABORATORIES ABBOTT ARCHITECT GLYCATED HEMOGLOBIN 11/01/1999
K992085 ABBOTT LABORATORIES ABBOTT IMX GLYCATED HEMOGLOBIN II 05/25/2000
K936285 ABBOTT LABORATORIES ABBOTT VISION GLYCATED HB, MODIFICATION 06/09/1995
K904027 ABBOTT LABORATORIES ABBOTT VISION(TM) GLYCATED HB 02/07/1991
K921831 ABBOTT LABORATORIES IMX(R) GLYCATED HEMOGLOBIN 09/29/1992
K171650 Abbott Rapid Diagnostics Alere Afinion HbA1c and ACR on Afinion 2 analyzer 11/21/2017
K151809 Alere Technologies AS Alere Afinion HbA1c, Alere Afinion AS100 Analyzer 09/25/2015
K113437 ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT 08/06/2012
K091711 ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023 12/11/2009
K170623 ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC ACE Hemoglobin A1c (HbA1c) Reagent 02/27/2018
K063306 ALFA WASSERMANN, INC. ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72 04/17/2007
K801561 AMERSHAM CORP. GLYCOSYLATED HEMOGLOBIN KIT 08/12/1980
K902457 ANALYTICAL CONTROL SYSTEMS, INC. ABNORMAL GLYCOHEMOGLOBIN CONTROL 07/24/1990
K902455 ANALYTICAL CONTROL SYSTEMS, INC. ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB) 07/24/1990
K792086 APPLIED CLINICAL RESEARCH LABORATORIES GLYCO-SPIN 11/30/1979
K803186 APPLIED CLINICAL RESEARCH LABORATORIES NORMAL AND ELEVATED CONTROL FOR GLYCO. 01/21/1981
K030553 ARKRAY, INC. ARKIT HBA1C 09/02/2003
K170147 ASAHI KASEI PHARMA CORPORATION Lucica Glycated Albumin-L 10/12/2017
K871679 AWARENESS TECHNOLOGY, INC. FOCUS-GHB 07/28/1987
K861697 AWARENESS TECHNOLOGY, INC. SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT) 08/19/1986
K121842 AXIS-SHIELD DIAGNOSTICS, LTD. ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C 12/12/2012
K072686 AXIS-SHIELD DIAGNOSTICS, LTD. AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS 03/17/2008
K110056 AXIS-SHIELD POC AS AFINION ANALYZER 02/15/2011
K050574 AXIS-SHIELD POC AS AFINION HBALC 07/22/2005
K955087 BAYER CORP. HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS 06/13/1996
K090413 BAYER HEALTHCARE, LLC A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC 05/14/2009
K791428 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC GLUCOHEMOGLOBIN CONTROL 08/22/1979
K780573 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC TECHNIQUE, CHROMATOGRAPHIC, HEMOGLOBIN 11/07/1978
K120199 BECKMAN COULTER, INC GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY 10/12/2012
K042459 BECKMAN COULTER, INC. SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT 11/17/2004
K010748 BECKMAN COULTER, INC. SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT 07/10/2001
K140829 BECKMAN COULTER, INC. UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT 07/14/2014
K121492 BECKMAN COULTER, INC. UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT 09/11/2012
K925204 BECKMAN INSTRUMENTS, INC. BECKMAN DIATRAC HEMOGLOB A1C ELECTRO KIT, MODIFIED 01/12/1993
K905709 BECKMAN INSTRUMENTS, INC. BECKMAN DIATRAC HEMOGLOBIN A ELECTROPHORESIS KIT 09/23/1991
K973696 BECKMAN INSTRUMENTS, INC. SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT 11/24/1997
K874749 BINAX, INC. BINAX EQUATE GLYCOHEMOGLOBIN 08/12/1988
K912748 BINAX, INC. BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT 10/31/1991
K882051 BIO-RAD BIO-RAD HEMOGLOBIN DETECTOR 08/01/1988
K811710 BIO-RAD BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST 07/15/1981
K781948 BIO-RAD COLUMN TEST, HEMOGLOBIN A 12/20/1978
K882222 BIO-RAD DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY 08/01/1988
K851636 BIO-RAD DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER SYSTEM 07/30/1985
K862371 BIO-RAD HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C) 09/16/1986
K822977 BIO-RAD HEMOGLOBIN ALC BY COLUMN TEST 11/16/1982
K830935 BIO-RAD HEMOGLOBIN ALC BY COLUMN TEST 06/16/1983
K831478 BIO-RAD LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN 06/22/1983
K871388 BIO-RAD MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER 07/06/1987
K935613 BIO-RAD RADIAS MONOCLONAL HBA 1C ASSAY 04/05/1994
K984268 BIO-RAD VARIANT II HEMOGLOBIN A1C PROGRAM 12/17/1998
K003280 BIO-RAD VARIANT II TOTAL GHB 12/19/2000
K941616 BIO-RAD VARIANT TOTAL GHB PROGRAM 04/14/1995
K926469 BIO-RAD VARIANT(TM) HEMOGLOBIN A 1C PROGRAM 03/29/1993
K063643 BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM 12/27/2006
K070819 BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716, 06/25/2007
K041444 BIO-RAD LABORATORIES, INC. BIO-RAD D-10 DUAL PROGRAM 06/09/2004
K031043 BIO-RAD LABORATORIES, INC. D-10 HEMOGLOBIN A1C 08/27/2003
K060001 BIO-RAD LABORATORIES, INC. D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM 01/20/2006
K040872 BIO-RAD LABORATORIES, INC. VARIANT II HEMOGLOBIN A1C 04/15/2004
K070452 BIO-RAD LABORATORIES, INC. VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU 05/07/2007
K090699 BIO-RAD LABORATORIES, INC. VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730 07/27/2009
K063400 BIO-RAD LABORATORIES, INC. VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0 12/01/2006
K140801 BIO-RAD LABORATORIES, INC. VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM 06/25/2014
K130860 BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE 04/25/2013
K122472 BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM 10/26/2012
K130990 BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS VARIANT(TM) II TURBO HBA1C KIT - 2.0 05/09/2013
K031296 BIODIAGNOSTIC INTL LIQUI-HEME GLYCO A1C ASSAY 10/15/2004
K161533 BioHermes Co., Ltd A1C EZ Glycohemoglobin Analysis System 06/16/2017
K991850 BIOSAFE LABORATORIES, INC. SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC 11/26/1999
K974491 BOEHRINGER MANNHEIM CORP. ACCU-CHEK A1C HEMOGLOBIN TEST 05/13/1998
K913614 BOEHRINGER MANNHEIM CORP. FRUCTOSAMINE ABG21 TEST SYSTEM 12/02/1991
K934070 BOEHRINGER MANNHEIM CORP. TINA-QUANT HEMOGLOBIN A1C 10/11/1994
K021484 CANTERBURY SCIENTIFIC LTD. HEMOGLOBIN A1C CONTROL 06/14/2002
K111128 CERAGEM INTERNATIONAL, INC. LABONACHECK A1C 09/13/2012
K820076 CLIN TECH DIAGNOSTICS CORP. GLYCO-SEP REAGENT TEST SET 02/12/1982
K031042 CLINICAL DATA, INC. ATAC HEMOGLOBIN A1C REAGENT KIT 11/03/2003
K852986 CLINICAL TECHNOLOGY CORP. GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN 08/19/1985
K802432 CLINTECH DIAGNOSTICS CORP. GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT. 12/01/1980
K812242 CORDIS CORP. CORDISNHYPERION HEMOGLOBIN A1 TEST SYS 09/09/1981
K811000 CORNING MEDICAL & SCIENTIFIC ABNORMAL GLYCOSYLATED HEMOGLOBIN CONTROL 05/08/1981
K791777 CORNING MEDICAL & SCIENTIFIC CORNING GLYCOSYLATED HEMOGLOBIN SET 11/13/1979
K896334 CREATIVE LABORATORY PRODUCTS, INC. CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER 12/11/1989
K896335 CREATIVE LABORATORY PRODUCTS, INC. CLP GLYCOSYLATED HEMOGLOBIN CONTROL-NR 12/11/1989
K011852 DADE BEHRING, INC. DIMENSION HAIC ASSAY, MODEL DF105 11/15/2001
K013465 DIABETES TECHNOLOGIES, INC. ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT 01/22/2002
K983172 DIABETES TECHNOLOGIES, INC. (DTI) ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT 11/30/1998
K930823 DIAGNOSTIC SPECIALTIES PROTEIN-BOUND GLUCOSE ASSAYN KIT 08/19/1993
K160762 DIAZYME LABORATORIES Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set 11/21/2016
K110188 DIAZYME LABORATORIES DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT 05/17/2011
K042193 DIAZYME LABORATORIES DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT 10/29/2004
K133803 DIAZYME LABORATORIES DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT 08/06/2014
K070734 DIAZYME LABORATORIES MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON 04/09/2007
K933287 DREW SCIENTIFIC LTD. 745 GLYCOMAT 09/09/1993
K920198 DREW SCIENTIFIC LTD. GLYCOMAT HAEMOGLOBIN ANALYSER 07/21/1992
K834294 EMD CHEMICALS INC. ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB 01/24/1984
K833805 ENDOCRINE SCIENCES PRODUCTS GLYCOGLOBIN KIT 01/03/1984
K780819 EPPENDORF-BRINKMANN, INC. GLYCOHEMOGLOBIN-SKREEN TEST KIT 11/07/1978
K893453 EXOCELL, INC. GLYCABEN 10/23/1989
K980888 EXOCELL, INC. GLYCACOR 08/13/1998
K973365 EXPRESS-MED, INC. AIC - CHEK (HBAIC-I) 06/15/1998
K971919 FLEXSITE DIAGNOSTICS, INC. EZCHEK/HBA BLOOD COLLECTION KIT 09/05/1997
K050178 GENERAL ATOMICS HBA1C ENZYMATIC ASSAY 06/28/2005
K983726 GENZYME CORP. GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL 11/25/1998
K000239 GENZYME CORP. GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL 03/21/2000
K833772 HELENA LABORATORIES AUTO AIC ANALYZER SYSTEM 01/18/1984
K901414 HELENA LABORATORIES COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581 06/15/1990
K921676 HELENA LABORATORIES COLUMNMATE II 07/10/1992
K946274 HELENA LABORATORIES COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN 07/11/1995
K790046 HELENA LABORATORIES G-HB QUIK COLUMN CONTROL 01/26/1979
K823869 HELENA LABORATORIES GLYCO HB QUIK COLUMN PROCEDURE 02/01/1983
K833356 HELENA LABORATORIES GLYCO-JE,E CPMTRP;-NORMAL/ABNORMAL 11/03/1983
K842689 HELENA LABORATORIES GLYCO-TEK AFFINITY COLUMN 10/15/1984
K921305 HELENA LABORATORIES GLYCO-TEK AFFINITY COLUMN KIT 06/09/1992
K802233 HELENA LABORATORIES GLYCOSYLATED HEMOGLOBIN-SMC COLUMN 10/10/1980
K800857 HELENA LABORATORIES HELENA GLYCOSYLATED HEMOGLOBIN QUIK METH 09/26/1980
K884315 HELENA LABORATORIES LABILE LYSING REAGENT 12/27/1988
K791135 HELENA LABORATORIES LYOPHILIZED G-HB QUIK COLUMN CONTROL 06/28/1979
K920820 HELENA LABORATORIES MODIFICATION COLUMNMATE 08/17/1992
K790583 HELENA LABORATORIES QUIK COLUMN METHODOLOGY 04/23/1979
K881863 HELENA LABORATORIES REP GLYCO SYSTEM 09/30/1988
K893224 HELENA LABORATORIES REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207 06/20/1989
K832087 HELENA LABORATORIES TITAN GEL GLYCO-HEME SYSTEM 08/24/1983
K880698 HELENA LABORATORIES TITAN GEL-PC GLYCO-HEME(TM) SYSTEM 05/06/1988
K940971 HERAEUS KULZER, INC. AMES DCA 2000 HEMOGLOBIN ALC CONTROLS 07/19/1994
K911625 HERAEUS KULZER, INC. AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM 09/05/1991
K951361 HERAEUS KULZER, INC. DCA 2000 SYSTEM FOR HEMOGLOBIN A1C 05/05/1995
K896830 HERAEUS KULZER, INC. OPTIMATE HEMOGLOBIN A1C 09/11/1990
K791365 HI CHEM, INC. FAST FLOW #60310 09/27/1979
K141944 HOME ACCESS HEALTH CORP. HOME ACCESS AIC TEST 03/13/2015
K073309 HORIBA ABX ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT 10/17/2008
K082275 INFOPIA CO., LTD CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023 01/14/2010
K121366 INFOPIA CO., LTD HEMOCUE HBA1C 501 09/07/2012
K141750 INFOPIA CO., LTD HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM 07/24/2014
K800794 ISOLAB, INC. FAST HEMOGLOBIN CONTROL-LYOPHILIZED 04/29/1980
K880673 ISOLAB, INC. GHB SAMPLE PAPER 11/22/1988
K822867 ISOLAB, INC. GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY 12/03/1982
K904814 ISOLAB, INC. GLYC-AFFIN GP 12/26/1990
K905513 ISOLAB, INC. GLYC-AFFIN(TM)-GA 01/15/1991
K873428 ISOLAB, INC. GLYCO-PROBE GSP 04/05/1988
K781851 ISOLAB, INC. HEMOGLOBIN, TESTING SYSTEM 11/07/1978
K080618 JAS Diagnostics, Inc. DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID 05/23/2008
K801289 LEECO DIAGNOSTICS, INC. LEECO GLYCO-HEMOGLOBIN DIAG. TEST KIT 06/30/1980
K791103 LEECO DIAGNOSTICS, INC. LEECO GLYCO-HEMOGLOBIN DIAGNOSTIC KIT 06/28/1979
K962597 LXN CORP. LXN FRUCTOSAMINE TEST SYSTEM 06/13/1997
K810958 MACOMB CHEMICAL CO. GLYCOHEMOGLOBIN 09/16/1981
K081269 MEC DYNAMICS CORP AVIE A1C TEST SYSTEM 03/20/2009
K093548 MEC DYNAMICS CORP AVIE A1C TEST SYSTEM 07/20/2011
K091400 MEC DYNAMICS CORP MODIFICATION TO AVIE A1C TEST SYSTEM 06/11/2009
K120497 MEDICA CORP. EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL 05/14/2012
K920397 MEDICAL ANALYSIS SYSTEMS, INC. REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT 08/04/1992
K983253 MEDISENSE, INC. PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT 11/20/1998
K033847 METRIKA, INC. A1CNOW FOR HOME AND PROFESSIONAL USE 12/23/2003
K022661 METRIKA, INC. A1CNOW FOR HOME USE 12/13/2002
K020235 METRIKA, INC. A1CNOW FOR PROFESSIONAL USE 02/15/2002
K020234 METRIKA, INC. A1CNOW FOR RX HOME USE 02/15/2002
K000887 METRIKA, INC. DRX HBA1C 07/26/2000
K000885 METRIKA, INC. DRX HBA1C - FOR PRESCRIPTION HOME USE 09/26/2000
K051321 METRIKA, INC. INVIEW 06/13/2005
K053411 MICROGENICS CORP. DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS 02/03/2006
K963844 MORAX HYDRAGEL 15 HB A1C KIT 04/22/1997
K031380 OLYMPUS AMERICA, INC. OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032) 11/14/2003
K811567 ORTHO DIAGNOSTIC SYSTEMS, INC. ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S 09/16/1981
K041764 ORTHO-CLINICAL DIAGNOSTICS THE VITROS 5,1 FS CHEMISTRY SYSTEM 09/09/2004
K060650 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702 04/06/2006
K990899 OSBORN GROUP, INC. HEMOCHEK-A1C SAMPLE COLLECTION KIT 12/21/1999
K984529 OSBORN LABORATORIES, INC. HEMOCHEK SAMPLE COLLECTION KIT 01/28/1999
K864643 PACIFIC HEMOSTASIS GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT 04/28/1987
K831837 PIERCE CHEMICAL CO. CLINOVATIVE II DIAGNOSTIC KIT 08/01/1983
K821360 PIERCE CHEMICAL CO. GLYCO-GEL TEST KIT 06/02/1982
K820279 PIERCE CHEMICAL CO. GLYCO-GEL TEST KIT 04/08/1982
K895661 PIERCE CHEMICAL CO. GLYCOTEST II GLYHB ASSAY KIT 12/07/1989
K993590 POINTE SCIENTIFIC, INC. FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET 12/21/1999
K860572 POINTE SCIENTIFIC, INC. GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET 05/16/1986
K031539 POINTE SCIENTIFIC, INC. HEMOGLOBIN A1C REAGENT SET 08/06/2003
K920449 POINTE SCIENTIFIC, INC. POINTE 750 GLYCOMETER 07/28/1992
K023654 POLYMEDCO, INC. GLYCA-DIRECT FRUCTOSAMINE 05/02/2003
K020532 POLYMEDCO, INC. POLYMEDCO HBA1C TEST 04/24/2002
K936204 PRIMUS CORP. GLYCATED HEMOGLOBIN CALIBRATORS 03/22/1994
K940143 PRIMUS CORP. GLYCATED HEMOGLOBIN CONTROLS 03/15/1994
K062658 PRIMUS CORP. PRIMUS A1CARE ASSAY 11/26/2007
K994045 PRIMUS CORP. PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2 12/21/1999
K992921 PRIMUS CORP. PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II 11/12/1999
K942009 PRIMUS CORP. PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY 09/14/1994
K112015 PRIMUS CORPORATION DBA TRINITY BIOTECH PREMIER HB9210 HBA1C ANALYZER 11/22/2011
K896582 PRIMUS, INC. DIABETES CARE(TM) TEST PACKAGE FOR THE CLC 330(TM) 06/28/1990
K993131 PRIMUS, INC. NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY 05/22/2000
K891235 PRIMUS, INC. PRIMUS MODEL CLC 330 06/16/1989
K041635 PROVALIS DIAGNOSTICS LTD. G5 I HBA1C TEST, G5 II HBA1C TEST 08/16/2004
K001392 PROVALIS DIAGNOSTICS LTD. GLYCOSAL HBA1C TEST 08/21/2000
K011933 PROVALIS DIAGNOSTICS LTD. GLYCOSAL II HBA 1C TEST 11/02/2001
K023763 RANDOX LABORATORIES, LTD. RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS 01/13/2003
K021897 RANDOX LABORATORIES, LTD. RANDOX HAEMOGLOBIN A1C 11/26/2002
K102914 ROCHE TQ HBA1C GEN3 01/20/2011
K854010 ROCHE DIAGNOSTIC SYSTEMS, INC. FRUCTOSAMINE TEST (ROCHE) 12/22/1987
K952337 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P 02/09/1996
K961674 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE UNIMATE FRUCTOSAMINE REAGENT 09/27/1996
K900718 ROCHE DIAGNOSTIC SYSTEMS, INC. ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY 06/12/1990
K110313 Roche Diagnostics TINA-QUANT HBA1C GEN.2 12/23/2011
K990992 ROCHE DIAGNOSTICS CORP. INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC 09/30/1999
K003120 ROCHE DIAGNOSTICS CORP. MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C 12/18/2000
K052464 ROCHE DIAGNOSTICS CORP. TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST 09/30/2005
K072714 ROCHE DIAGNOSTICS CORP. TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM 04/18/2008
K163633 Roche Diagnostics Operations cobas HbA1c Test, cobas b 101 system 07/28/2017
K130014 Sakae Corporation A1C GEAR SYSTEM 04/04/2014
K142789 Sakae Corporation A1c iGear System 12/16/2014
K872852 SANDARE CHEMICAL CO., INC. EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST 09/29/1987
K802832 SANDARE CHEMICAL CO., INC. SANDARE GLYCOHEMOGLOBIN PROCEDURE 01/16/1981
K862556 SANDARE CHEMICAL CO., INC. SANDARE GLYCOHEMOGLOBIN PROCEDURE 08/08/1986
K801422 SANDARE CHEMICAL CO., INC. SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS. 07/08/1980
K140827 SD Biosensor, Inc. SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set 09/30/2015
K162281 SEBIA CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) 02/17/2017
K122101 SEBIA CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C 12/06/2012
K133344 SEBIA MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS 03/28/2014
K100547 SEPPIM S.A.S. ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL 05/19/2011
K033674 SERADYN INC. MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS 02/09/2004
K810638 SHERWOOD MEDICAL CO. LANCER GLYCOSYLATED HEMOGLOBIN 05/08/1981
K810714 SHERWOOD MEDICAL CO. LANCER GLYCOSYLATED HEMOGLOBIN ASSAY 05/08/1981
K110934 SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY 08/25/2011
K102510 SIEMENS HEALTHCARE DIAGNOSTICS DIMENSIONS HB1C KIT, MODEL DF105A 05/13/2011
K131307 SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR 01/24/2014
K102045 SIEMENS HEATLHCARE DIAGNOSTICS INC DIMENSION VISA HBA1C, MODEL K3105A 02/14/2011
K081895 SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS 01/08/2009
K071466 SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS DCA VANTAGE, MODEL 5075 10/09/2007
K802721 SIGMA CHEMICAL CO. GLYCOHEMOGLOBIN IN WHOLE BLOOD 12/11/1980
K012410 SIGMA DIAGNOSTICS, INC. INFINITY HBA KIT, MODELS 537-A, 537-B 10/26/2001
K884184 SIGMA DIAGNOSTICS, INC. SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE 03/28/1989
K142664 TAIDOC TECHNOLOGY CORPORATION URight Hemoglobin A1c system, FORA A1c System 01/29/2016
K931183 TECO DIAGNOSTICS GLYCOHEMOGLOBIN 11/05/1993
K051200 TECO DIAGNOSTICS HEMOGLOBIN A1C REAGENT SET 08/08/2005
K012525 THERMO DMA, INC. THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235 10/04/2001
K063209 THERMO ELECTRON OY HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL 03/21/2007
K852111 THYROID DIAGNOSTICS, INC. GLYCO-CHECK 07/05/1985
K071132 Tosoh BioScience, Inc. G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8 09/16/2008
K100304 Tosoh BioScience, Inc. ST AIA PACK HBA1C 08/27/2010
K972265 TOSOH MEDICS, INC. A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER 09/25/1997
K011434 TOSOH MEDICS, INC. G7 AUTOMATED HPLC ANALYZER 09/18/2001
K875354 ULSTER SCIENTIFIC, INC. UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM 02/17/1988


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact