FDA 510(k) Applications for Medical Device Product Code "JJX"
(Single (Specified) Analyte Controls (Assayed And Unassayed))

FDA 510(k) Number Applicant Device Name Decision Date
K870151 3M COMPANY TOTAL/IGE THEOPHYLLINE CONTROL SERA 03/12/1987
K143026 AALTO SCIENTIFIC LTD. Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity 11/21/2014
K100750 AALTO SCIENTIFIC LTD. AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5 05/21/2010
K130157 AALTO SCIENTIFIC LTD. AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET 03/19/2013
K100715 AALTO SCIENTIFIC LTD. AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5 12/23/2010
K101427 AALTO SCIENTIFIC LTD. AUDIT MICROCV HS-CRP LINEARITY SET 12/23/2010
K112143 AALTO SCIENTIFIC LTD. AUDIT MICROCV T-UPTAKE LINEARITY 01/31/2012
K130764 AALTO SCIENTIFIC LTD. AUDIT MICROCV VITAMIN D LINEARITY SET 04/26/2013
K161874 AALTO SCIENTIFIC, LTD. Audit MicroControls Linearity DROP LQ Blood Glucose 08/10/2016
K143571 AALTO SCIENTIFIC, LTD. Audit MicroControls Linearity LQ Cystatin-C 01/23/2015
K970527 ABBOTT LABORATORIES ABBOTT HCG SERUM CONTROLS 03/03/1997
K041687 ABBOTT LABORATORIES ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR 08/18/2004
K935611 ABBOTT LABORATORIES AXSYM LUTEINIZING HORMONE (LH) 06/21/1994
K863126 ABBOTT LABORATORIES TESTPACK ACUTE HCG SERUM CONTROLS 09/15/1986
K112653 ACON LABORATORIES, INC. ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS 04/09/2012
K960378 ACTIMED LABORATORIES, INC. ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS 04/03/1996
K885282 ACTIO, INC. ASSAYED CHOLINESTERASE CONTROL 06/09/1989
K083549 AMERICAN BIOLOGICAL TECHNOLOGIES, INC. ABT GLUCOSE CONTROL SOLUTION 12/22/2008
K091460 AMERICAN BIOLOGICAL TECHNOLOGIES, INC. ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087 08/06/2009
K090854 AMERICAN BIOLOGICAL TECHNOLOGIES, INC. ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090 04/16/2009
K090943 AMERICAN BIOLOGICAL TECHNOLOGIES, INC. ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089 05/27/2009
K823687 AMERICAN MONITOR CORP. BIO INTERFERENCE BLANKING MATERIAL 01/07/1983
K902760 AMERSHAM CORP. AMERSHAM TSH CONTROL SERA 07/27/1990
K800708 AMERSHAM CORP. CODE QAS.105 PROLACTIN CONTROL SERA 04/16/1980
K894329 AMERSHAM CORP. RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL 09/05/1989
K991075 AMIRA MEDICAL, INC. ATLAST GLUCOSE CONTROL SOLUTION 05/10/1999
K940272 ANALYTICAL CONTROL SYSTEMS, INC. ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL 04/20/1994
K911176 ANALYTICAL CONTROL SYSTEMS, INC. ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL I 05/01/1991
K911177 ANALYTICAL CONTROL SYSTEMS, INC. ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL II 05/01/1991
K911178 ANALYTICAL CONTROL SYSTEMS, INC. ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III 05/01/1991
K925906 ANALYTICAL CONTROL SYSTEMS, INC. NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL 02/18/1993
K100747 APEX BIO TECHNOLOGY CORP CONTREX PLUS LOW CONTROL SOLUTION 04/14/2010
K821742 ARMKEL, LLC. POSITIVE & NEGATIVE HCG URINE CONTROLS 07/02/1982
K896875 ARMKEL, LLC. POSITIVE AND NEGATIVE HCG SERUM CONTROLS 02/26/1990
K894181 ARMKEL, LLC. POSITIVE AND NEGATIVE HCG URINE CONTROLS 08/31/1989
K914809 ARTEL, INC. MP MINI PHOTOMETER 01/27/1992
K892656 AWARENESS TECHNOLOGY, INC. DRI-DYE CHECK STRIPS (TM)-405 05/22/1989
K001651 AXIS-SHIELD BIOCHEMICALS, ASA BIO-RAD %CDT TIA 11/22/2000
K020217 BAYER DIAGNOSTICS CORP. ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY 03/15/2002
K151742 BAYER HEALTHCARE Contour Next Control Solution 09/23/2015
K935362 BECKMAN P-AMYLASE CONTROL 01/27/1994
K981864 BECKMAN COULTER, INC. ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219 06/12/1998
K993210 BECKMAN COULTER, INC. ACCESS HYBRITECH FREE PSA QC, MODEL 37219 01/05/2000
K112603 BECKMAN COULTER, INC. ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS 11/04/2011
K994200 BECKMAN COULTER, INC. ACCESS HYBRITECH PSA QC, MODEL 37209 01/18/2000
K994277 BECKMAN COULTER, INC. ACCESS OSTASE QC 01/14/2000
K010428 BECKMAN COULTER, INC. ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349 03/13/2001
K001458 BECKMAN COULTER, INC. SYNCHRON CONTROL 06/02/2000
K010693 BECKMAN COULTER, INC. VIGIL DNASE B CONTROL 04/11/2001
K982022 BECKMAN COULTER, INC. VIGIL HEMOGLOBIN (HBALC) CONTROLS 07/06/1998
K791031 BECKMAN INSTRUMENTS, INC. ABNORMAL PROTEIN ELECTROPHORESIS CONTROL 07/17/1979
K851079 BECKMAN INSTRUMENTS, INC. BECKMAN TRIGLYCERIDES CONTROL LEVELS 1/2 &3 04/10/1985
K791141 BECKMAN INSTRUMENTS, INC. BILIRUBIN CALIBRATOR CONTROL 08/10/1979
K791029 BECKMAN INSTRUMENTS, INC. NORMAL PROTEIN ELECTROPHORESIS CONTROL 07/17/1979
K944453 BECKMAN INSTRUMENTS, INC. QUANTITATE URIC ACID VERIFIER SET 11/22/1994
K802068 BECKMAN INSTRUMENTS, INC. ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO 10/10/1980
K962694 BEHRING DIAGNOSTICS, INC. OPUS B12 CONTROLS 07/22/1996
K954144 BEHRING DIAGNOSTICS, INC. OPUS HCG CONTROLS 10/06/1995
K973832 BEHRING DIAGNOSTICS, INC. OPUS HLH CONTROLS 10/27/1997
K962841 BEHRING DIAGNOSTICS, INC. OPUS MYOGLOBIN CONTROLS 08/15/1996
K955468 BEHRING DIAGNOSTICS, INC. OPUS PROLACTIN CONTROLS 02/23/1996
K961206 BEHRING DIAGNOSTICS, INC. OPUS T3 CONTROLS 04/23/1996
K953097 BEHRING DIAGNOSTICS, INC. OPUS T4 CONTROLS 08/24/1995
K791957 BHP DIAGNOSTIX, INC. SERACON -LO DO26 10/11/1979
K904503 BHP DIAGNOSTIX, INC. SERACON CR REFERENCE 11/02/1990
K782171 BHP DIAGNOSTIX, INC. SERACON-HDL 02/08/1979
K782170 BHP DIAGNOSTIX, INC. SERACON-LP 02/15/1979
K881430 BIO DIAGNOSTIC INTL. LIQUI-SERA SERUM ALCOHOL CONTROLS 07/08/1988
K990162 BIO-RAD ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01 01/28/1999
K992781 BIO-RAD ARCHITECH AFP MASTERCHECK, MODEL 6C01-05 04/05/2000
K984626 BIO-RAD ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5 01/29/1999
K990608 BIO-RAD ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05 03/30/1999
K984604 BIO-RAD ARCHITECT ESTRADIOL MASTERCHEK, MODEL # 6C22-05 02/02/1999
K984625 BIO-RAD ARCHITECT FOLATE MASTERCHEK, MODEL # 6C12-05 02/02/1999
K984319 BIO-RAD ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05 12/22/1998
K984070 BIO-RAD ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05 11/25/1998
K984318 BIO-RAD ARCHITECT FSH MASTERCHECK, MODEL NUMBER 6C24-05 12/15/1998
K984323 BIO-RAD ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05 12/15/1998
K990393 BIO-RAD ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05 03/22/1999
K984324 BIO-RAD ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05 12/15/1998
K983578 BIO-RAD ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05 11/12/1998
K984073 BIO-RAD ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05 11/25/1998
K984327 BIO-RAD ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05 12/22/1998
K984072 BIO-RAD ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05 11/24/1998
K042837 BIO-RAD LIQUICHEK ELEVATED CRP CONTROL 11/02/2004
K984071 BIO-RAD LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644 12/03/1998
K921089 BIO-RAD LYPHOCHEK(R) FRUCTOSAMINE CONTROL 04/29/1992
K891475 BIO-RAD LYPHOCHEK(R) IMMUNOASSAY CONTR SERUM (HUMAN) 1,2,3 08/01/1989
K961432 BIO-RAD RADIAS GALT TEST 10/28/1996
K123798 Bio-Rad Laboratories LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK 01/09/2013
K953883 BIO-RAD LABORATORIES, INC. ACCESS LOW LEVEL IGE CONTROLS 11/14/1995
K043584 BIO-RAD LABORATORIES, INC. LIQUICHEK BNP CONTROL 02/08/2005
K963551 BIOCELL LABORATORIES, INC. BIO-CSF LIQUID CONTROL LEVEL 1 AND 2 10/07/1996
K000056 BIOCELL LABORATORIES, INC. BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS 02/24/2000
K050328 BIOCHEMICAL DIAGNOSTIC, INC. PREGNANCY-SKREEN 03/29/2005
K060027 BIOKIT S.A. ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH) 01/26/2006
K823353 BIOLOGICS INTL., INC. CARCINO-CEK 12/14/1982
K133003 BIONIME CORPORATION RIGHTEST CONTROL SOLUTION 10/24/2013
K002540 BIONOSTICS, INC. BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS 09/18/2000
K000318 BIONOSTICS, INC. BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM 02/28/2000
K021697 BIONOSTICS, INC. GLUCOSE CONTROL SOLUTION FOR BD LATITUDE 07/12/2002
K032819 BIONOSTICS, INC. GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM 10/20/2003
K013147 BIONOSTICS, INC. GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE 10/24/2001
K112352 BIONOSTICS, INC. GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT 12/23/2011
K112356 BIONOSTICS, INC. GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE 09/19/2011
K082395 BIONOSTICS, INC. GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002 09/18/2008
K081403 BIONOSTICS, INC. GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK 07/25/2008
K123966 BIONOSTICS, INC. GLUCOSE METER-CHECK SOLUTION FOR BAYER 01/25/2013
K113764 BIONOSTICS, INC. GLUCOSE METER-CHECK SOLUTION FOR INFOPIA 01/30/2012
K123851 BIONOSTICS, INC. GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK 02/14/2013
K131136 BIONOSTICS, INC. GLUCOSE METER-CHECK SOLUTION FOR TAIDOC 05/31/2013
K103553 BIONOSTICS, INC. LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION 02/10/2011
K022769 BIONOSTICS, INC. LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION 11/13/2002
K012430 BIONOSTICS, INC. MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3 08/27/2001
K091914 BIONOSTICS, INC. OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION 11/06/2009
K053327 BIONOSTICS, INC. OXICOM CONTROL 01/26/2006
K021624 BIONOSTICS, INC. RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4 07/12/2002
K081478 BIONOSTICS, INC. RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS 10/06/2008
K050961 BIONOSTICS, INC. RNA1C CONTROL FOR NYCOCARD HBA1C 05/13/2005
K050100 BIONOSTICS, INC. RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER 02/25/2005
K000230 BIOSITE INCORPORATED TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS 02/29/2000
K000231 BIOSITE INCORPORATED TRIAGE BNP CALIBRATION VERIFICATION CONTROLS 03/02/2000
K905280 BIOTROL, USA, INC. BIOTROL BILIRUBIN C & T CONTROL 02/04/1991
K855225 BOEHRINGER MANNHEIM CORP. ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL 01/17/1986
K982471 BOEHRINGER MANNHEIM CORP. B2-MICROGLOBULIN CONTROL SET SERUM 08/06/1998
K970452 BOEHRINGER MANNHEIM CORP. ELECSYS CALCHECK CEA 03/06/1997
K970459 BOEHRINGER MANNHEIM CORP. ELECSYS CALCHECK CEA 03/06/1997
K963182 BOEHRINGER MANNHEIM CORP. ELECSYS CALCHECK CK-MB 08/23/1996
K970148 BOEHRINGER MANNHEIM CORP. ELECSYS CALCHECK ESTRADIOL 02/10/1997
K963163 BOEHRINGER MANNHEIM CORP. ELECSYS CALCHECK FT3 08/27/1996
K963164 BOEHRINGER MANNHEIM CORP. ELECSYS CALCHECK FT4 08/27/1996
K963165 BOEHRINGER MANNHEIM CORP. ELECSYS CALCHECK HCG 08/30/1996
K964830 BOEHRINGER MANNHEIM CORP. ELECSYS CALCHECK LH 12/16/1996
K970458 BOEHRINGER MANNHEIM CORP. ELECSYS CALCHECK PSA 03/06/1997
K963181 BOEHRINGER MANNHEIM CORP. ELECSYS CALCHECK T UPDATE 09/10/1996
K963178 BOEHRINGER MANNHEIM CORP. ELECSYS CALCHECK T4 08/27/1996
K970146 BOEHRINGER MANNHEIM CORP. ELECSYS CALCHECK TESTOSTERONE 01/30/1997
K963143 BOEHRINGER MANNHEIM CORP. ELECSYS CALCHECK TROPONIN T 08/23/1996
K963147 BOEHRINGER MANNHEIM CORP. ELECSYS CALCHECK TSH 08/23/1996
K974383 BOEHRINGER MANNHEIM CORP. ELECSYS CALCHECK VITAMIN B12 12/08/1997
K962573 BOEHRINGER MANNHEIM CORP. ELECSYS PRECICONTROL TSH 07/22/1996
K963167 BOEHRINGER MANNHEIM CORP. ELECYS CALCHECK T 3 08/27/1996
K973358 BOEHRINGER MANNHEIM CORP. MYOGLOBIN CONTROL SET 10/06/1997
K902569 BOEHRINGER MANNHEIM CORP. PRECINORM HDL CHOLESTEROL CONTROL MATERIAL FOR REF 08/09/1990
K811832 BOEHRINGER MANNHEIM CORP. PRECINORM U & PRECIPATH U HUMAN SERUM 07/15/1981
K843569 BOEHRINGER MANNHEIM CORP. PRECISET AMMONIA 09/28/1984
K970984 BOEHRINGER MANNHEIM CORP. THE ELECSYS CALCHECK PROGESTERONE 04/02/1997
K974811 BOSTON BIOMEDICA, INC. ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL 02/10/1998
K823186 BRL ESTROCEPT STABILIZED ESTROGEN RECEPTOR 01/07/1983
K926015 CALA DIAGNOSTICS CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3 12/28/1992
K930874 CALA DIAGNOSTICS LD-1 CONTROL-LEVEL 1 & 2 04/22/1993
K071648 CANTERBURY SCIENTIFIC LTD. EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS 08/22/2007
K043070 CANTERBURY SCIENTIFIC LTD. LIQUID STABLE HBA1C CONTROL 12/09/2004
K923794 CASCO STANDARDS DOCUMENT CHEM II CALIBRATION VERIFICATION TEST SET 11/05/1992
K923793 CASCO STANDARDS DOCUMENT CHEM III CALIBRATION VERIFICATION TEST 11/05/1992
K932870 CASCO STANDARDS DOCUMENT CHEM IV CALIBRATION VERIFICATION TEST SET 08/02/1993
K923821 CASCO STANDARDS DOCUMENT CHEM V CALIBRATION VERIFICATION TEST SET 11/05/1992
K944338 CASCO STANDARDS DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET 11/15/1994
K944361 CASCO STANDARDS DOCUMENT R AMMONIA/ETHANOL CONTROL 11/30/1994
K924493 CASCO STANDARDS DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD 01/11/1993
K945718 CASCO STANDARDS DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET 01/17/1995
K940568 CASCO STANDARDS DOCUMENT(R) ZERO 04/05/1994
K893140 CASCO STANDARDS DOCUMENT(TM) TRIGLYCERIDE LINEARITY TEST SET 06/23/1989
K983432 CHRONIMED, INC. SUPREME II CONTROL SOLUTIONS 12/17/1998
K961510 CIBA CORNING DIAGNOSTICS CORP. ACS FRT4 IMMUNOASSAY 06/17/1996
K873450 CIBA CORNING DIAGNOSTICS CORP. TRI-LEVEL LIGAND CONTROL 09/21/1987
K946143 CLINICAL CONTROLS, INC. CHEMSPEX(TM) AMMONIA CONTROL 02/03/1995
K962432 CLINICAL CONTROLS, INC. LIQUISPEX URINE (MICRO)ALBUMIN CONTROL 07/05/1996
K946144 CLINICAL CONTROLS, INC. LIQUISPEX(TM) URINE ETHANOL CONTROL 02/08/1995
K964278 CLINICAL CONTROLS, INC. WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6 11/22/1996
K121237 CLINIQA CORPORATION BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE 05/18/2012
K052679 CLINIQA CORPORATION CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E 11/18/2005
K041898 CLINIQA CORPORATION CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM 08/16/2004
K022232 CLINIQA CORPORATION CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3 08/01/2002
K022491 CLINIQA CORPORATION LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS 08/27/2002
K022758 CLINIQA CORPORATION LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN II NEPHELOMETER 09/17/2002
K040927 CLINIQA CORPORATION LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS 05/17/2004
K040455 CLINIQA CORPORATION LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS 03/05/2004
K925783 COGENT DIAGNOTICS LTD. AUTOSTAT ANTI-DSDNA 03/22/1993
K060570 COMPASS BIOSCIENCE HEMOGLOBIN ALC CONTROL 04/13/2006
K121534 CONE BIOPRODUCTS CONE-TROL HEMOGLOBIN A1C CONTROL SET 06/20/2012
K052010 CONE BIOPRODUCTS HBA1C LINEARITY SET 10/04/2005
K913496 CREATIVE LABORATORY PRODUCTS, INC. CHOLINESTERASE LINEARITY CONTROL 09/11/1991
K950589 CREATIVE LABORATORY PRODUCTS, INC. CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROL-HL 03/20/1995
K942284 CREATIVE LABORATORY PRODUCTS, INC. CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SET 08/26/1994
K913585 CREATIVE LABORATORY PRODUCTS, INC. LIPASE LINEARITY CONTROL 10/21/1991
K922995 CREATIVE LABORATORY PRODUCTS, INC. LIPID CONTROLS 08/12/1992
K981622 DADE BEHRING, INC. DADE TRU-LIQUID CARDIAC CONTROL 06/08/1998
K982591 DADE BEHRING, INC. DADE TRU-LIQUID CARDIAC CONTROL 08/05/1998
K013130 DADE BEHRING, INC. N LP(A) CONTROL SY 10/18/2001
K973099 DADE CHEMISTRY SYSTEMS, INC. PROSTATE SPECIFIC ANTIGEN CONTROL 09/29/1997
K951888 DADE INTL., INC. DADE STRATUS TROPONIN-I CONTROL 07/13/1995
K972287 DADE INTL., INC. DADE TRU-LIQUID BILIRUBIN CONTROL 07/07/1997
K955796 DATA MEDICAL ASSOCIATES, INC. IRON CALIBRATOR & CALIBRATION VERIFICATION SET 02/29/1996
K983971 DIAGNOSTIC PRODUCTS CORP. CARDIAC MARKER CONTROL MODULE, MODEL CCCM 11/18/1998
K963240 DIAGNOSTIC PRODUCTS CORP. IMMULITE ACTH CONTROL MODULE (LACCM) 08/29/1996
K952251 DIAGNOSTIC PRODUCTS CORP. IMMULITE HCG HIGH LEVEL CONTROL MODULE 09/08/1995
K971051 DIAGNOSTIC PRODUCTS CORP. IMMULITE THYROID AUTOANTIBODY CONTROL MODULE 04/10/1997
K930007 DIAGNOSTIC PRODUCTS CORP. IMMULITE TSH THIRD GENERATION CONTROL 08/16/1993
K950072 DIAGNOSTIC PRODUCTS CORP. IMMULITE(R) TBG 04/03/1995
K915806 DIAGNOSTIC PRODUCTS CORP. MILENIA DATA REDUCTION 01/30/1992
K962975 DIAGNOSTIC PRODUCTS CORP. PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM) 08/29/1996
K960154 DIAGNOSTIC PRODUCTS CORP. PSA CONTROLS 03/13/1996
K932113 DIAGNOSTIC REAGENTS, INC. CANNABINOID URINE CONTROLS 06/29/1993
K161526 DiaSorin Inc. LIAISON CMV IgM Serum Control Set 06/30/2016
K161522 DiaSorin Inc. LIAISON EBV IgM Serum Control Set 06/30/2016
K090104 DIASORIN, INC. LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603 09/09/2009
K093498 DIASORIN, INC. LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913 12/14/2009
K092911 DIAZYME LABORATORIES SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER 04/26/2010
K963909 DIRECT SOLUTIONS HEMOCUE GLUCOLIN 11/08/1996
K964053 DIRECT SOLUTIONS HEMOCUE GLUCOTROL 11/01/1996
K060510 DREW SCIENTIFIC LTD. DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT 06/19/2006
K771798 E.I. DUPONT DE NEMOURS & CO., INC. ACA BILIRUBIN CALIBRATOR 10/28/1977
K772285 E.I. DUPONT DE NEMOURS & CO., INC. ACA LIPASE VERIFIERS 01/06/1978
K790376 E.I. DUPONT DE NEMOURS & CO., INC. DUPONT ACA CKMB VERIFIERS 04/04/1979
K904306 E.I. DUPONT DE NEMOURS & CO., INC. DUPONT DRUG CALIBRATOR-A 10/15/1990
K925880 EASTMAN KODAK COMPANY KODAK AMERLITE CK-MB CONTROL SERA LAN.4413 02/05/1993
K861221 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST 04/24/1986
K801854 ENVIRONMENTAL CHEMICAL SPECIALTIES SPINAL FLUID CONTROL(HUMAN) 09/16/1980
K060215 EUROTROL B.V. ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002 03/24/2006
K080273 FUJIREBIO DIAGNOSTICS TEXAS, INC. AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION 08/08/2008
K081915 FUJIREBIO DIAGNOSTICS TEXAS, INC. FDTX GLUCOSE CONTROL SOLUTION 08/08/2008
K110436 FUJIREBIO DIAGNOSTICS, INC FDI GLUCOSE CONTROL SOLUTION FOR AVIVA 04/20/2011
K103450 FUJIREBIO DIAGNOSTICS, INC FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE 01/25/2011
K102260 FUJIREBIO DIAGNOSTICS, INC FDI GLUCOSE CONTROL SOLUTIONS 09/24/2010
K110641 FUJIREBIO DIAGNOSTICS, INC FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL 05/27/2011
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