FDA 510(k) Applications for Medical Device Product Code "CGX"
(Alkaline Picrate, Colorimetry, Creatinine)

FDA 510(k) Number Applicant Device Name Decision Date
K873131 A-KEM, INC. CREATININE REAGENT KIT 10/23/1987
K991109 A.P. TOTAL CARE, INC. CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02 05/25/1999
K873310 ABBOTT LABORATORIES ABBOTT SPECTRUM(R) LIQUID CREATININE REAGENT 09/02/1987
K981799 ABBOTT LABORATORIES CREA 07/22/1998
K083809 ABBOTT LABORATORIES CREATININE 04/07/2009
K981240 ABBOTT LABORATORIES CREATININE (CREA) 05/29/1998
K771365 ABBOTT LABORATORIES CREATININE ANALYSIS PRODUCTS 08/16/1977
K843916 ABBOTT LABORATORIES TDX REA CREATININE 10/30/1984
K854846 ABBOTT LABORATORIES VISION CREATININE 01/13/1986
K061193 ABBOTT LABORATORIES INC CREATININE 06/23/2006
K841377 ADVANCED ANALYTICAL SYSTEMS, INC. CREATININE - A.A.S. 05/11/1984
K844332 ADVANCED BIOMEDICAL METHODS, INC. CREATININE REAGENT FOR DEMAND ANALYZER 01/03/1985
K851993 ALPKEM CORP. CRE BUFFER CRE DYE 05/30/1985
K830447 AMERICAN MONITOR CORP. KINETIC CREATININE 03/24/1983
K770242 AMERICAN MONITOR CORP. REAGENT SYSTEM 02/22/1977
K896686 AMERICAN RESEARCH PRODUCTS CO. AMRESCO CREATININE REAGENT #4316100 02/08/1990
K900666 AMERICAN RESEARCH PRODUCTS CO. AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791 04/19/1990
K853888 AMERICAN RESEARCH PRODUCTS CO. AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 & 10/15/1985
K831627 AMERICAN SCIENTIFIC PRODUCTS CREATININE REAGENTS B6360-10 07/06/1983
K831628 AMERICAN SCIENTIFIC PRODUCTS CREATININE REAGENTS B6370-13 07/06/1983
K832439 AMRESCO, INC. CREATININE REAGENT SET 01/17/1984
K830537 AMRESCO, INC. FLOW-PAC CREATININE REAGENT SET 03/24/1983
K813560 AMRESCO, INC. LIQUIZYME CREATININE REAGENT SET 01/29/1982
K823806 ANALYTICAL & RESEARCH CHEMICALS, INC. DIRECT CREATININE PROCEDURE 01/14/1983
K812834 ANCO MEDICAL REAGENTS & ASSOC. CREATININE REAGENT SET 12/03/1981
K050652 ARKRAY, INC. SPOTCHEM II CREATININE, AMYLASE & ALP TESTS 04/06/2005
K873531 BAXTER HEALTHCARE CORP. PARAMAX CREATININE REAGENT 11/23/1987
K071280 BECKMAN COULTER, INC. SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS 06/01/2007
K071277 BECKMAN COULTER, INC. SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS 06/01/2007
K060935 BECKMAN COULTER, INC. SYNCHRON SYSTEMS CREATININE (CREA) REAGENT 04/28/2006
K071283 BECKMAN COULTER, INC. SYNCHRON SYSTEMS CREATININE REAGENT 06/01/2007
K771335 BECKMAN INSTRUMENTS, INC. CREATININE ANALYZER 2 08/03/1977
K915077 BECKMAN INSTRUMENTS, INC. SYNCHRON CREATININE TRIGGERED TEST CX4,5,7, 12/18/1991
K905619 BIOCHEMICAL TRADE, INC. CREATININE (RATE) REAGENT SET 02/13/1991
K881856 BIOTROL, USA, INC. BIOTROL CREATININE H.P. REAGENT 06/16/1988
K971908 CAROLINA LIQUID CHEMISTRIES CORP. CREA OR CREATININE 06/17/1997
K881400 CATACHEM, INC. CREATININE FOR CONTINUOUS FLOW INSTRUMENTS 04/28/1988
K811406 CHEM-ELEC, INC. CREATININE RATE REAGENT KIT 08/13/1981
K950142 CHIMERA RESEARCH & CHEMICAL, INC. CR PERFECT 05/25/1995
K970087 CHIMERA RESEARCH & CHEMICAL, INC. CR PERFECT 03/06/1997
K854178 CLINICAL DATA, INC. IN-VITRO TEST FOR THE DETERMINATION OF CREATININE 11/25/1985
K791994 CONNECTICUT DIAGNOSTICS, LTD. CREATININE DIAG. REAGENT PICRIC ACID 10/17/1979
K902172 COULTER CORP. COULTER CREATININE REAGENT 06/28/1990
K861655 DATA MEDICAL ASSOCIATES, INC. CREATININE PROCEDURE 07/01/1986
K863261 DATA MEDICAL ASSOCIATES, INC. CREATININE PROCEDURE 10/02/1986
K955938 DERMA MEDIA LAB., INC. CREATININE REAGENT 03/12/1996
K934587 DIAGNOSTIC CHEMICALS LTD. CREATININE-S ASSAY 03/11/1994
K000055 DIAGNOSTIC CHEMICALS LTD. CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17 02/18/2000
K843377 DIAGNOSTIC CHEMICALS, LTD. (USA) CREATININE ASSAY KIT 09/28/1984
K842159 DIAGNOSTIC CHEMICALS, LTD. (USA) CREATININE ASSAY KIT-KINETIC OR ENDPOINT 08/16/1984
K800685 DIAGNOSTIC SOLUTIONS, INC. REAGENT FOR DETERM. CREATININE IN H/SERU 05/28/1980
K033058 DIAMOND DIAGNOSTICS, INC. CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS 01/30/2004
K850932 DILAB, INC. CREATININE 06/25/1985
K925668 E.I. DUPONT DE NEMOURS & CO., INC. CREATININE METH FOR USE ON THE DIMENSION CLIN CHEM 12/28/1992
K861819 EASTMAN KODAK COMPANY KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CREA) 06/11/1986
K934071 EASTMAN KODAK COMPANY KODAK EKTACHEM DT SLIDES (URCR) 03/21/1994
K023407 ELAN DIAGNOSTICS ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR 02/14/2003
K913707 EM DIAGNOSTIC SYSTEMS, INC. ABBOTT QUICKSTART CREATININE TEST(CREA) ITEM# 5A28 09/18/1991
K884734 EM DIAGNOSTIC SYSTEMS, INC. CREATININE TEST (CREA) ITEM #65663 12/19/1988
K924599 EM DIAGNOSTIC SYSTEMS, INC. CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2 10/15/1992
K874088 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST CREATININE (CREA) ITEM NO. 19009 11/06/1987
K863738 EM DIAGNOSTIC SYSTEMS, INC. EMDS(TM) CREATININE(CREA) TESTPACKS, #67669/95 11/05/1986
K905658 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE CREATININE (EPOS APPLICATION) #65413 05/08/1991
K843105 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE CREATININE 67223 08/27/1984
K923203 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE CREATININE TEST 09/09/1992
K895022 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE CREATININE TEST (CREA) #65413 10/23/1989
K932160 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE CREATININE TEST ITEM NUMBER 65413 07/09/1993
K822118 FERMCO BIOCHEMICS, INC. FERMCOTEST CREATININE TEST REAGENT 09/30/1982
K800219 FISHER SCIENTIFIC CO., LLC. SERUM CREATININE; ALK. BUFFER & PICRIC 02/26/1980
K781884 FISHER SCIENTIFIC CO., LLC. SERUM, CREATININE DETERMINATIONS 12/20/1978
K771834 GAMMA ENTERPRISES, INC. CREATININE 11/03/1977
K040976 GENCHEM, INC. GENCHEM CREATININE REAGENT 12/27/2004
K811659 GILFORD DIAGNOSTICS CREATININE REAGENT 06/26/1981
K812109 GILFORD DIAGNOSTICS GILCHEM CREATININE REAGENT 08/13/1981
K761279 HARLECO AUTO CREATININE REAGENT (ABBOTT SYSTEM) 02/11/1977
K761280 HARLECO AUTO CREATININE REAGENT (GILFORD 3400-E) 02/14/1977
K771773 HARLECO CLINICARD CREATININE CHEMISTRY 10/14/1977
K772107 HARLECO CREATININE URINE APPLI.-#32308 11/28/1977
K772157 HARLECO CREATININE, 64972 12/06/1977
K813043 HARLECO ULTRACHEM CREA ITEM #64972 11/10/1981
K770819 HARLECO ULTRACHEM CREATININE 07/11/1977
K780514 HARLECO ULTRACHEM CREATININE 64972, CENTRIFUCHEM 05/19/1978
K821881 HARLECO DIAGNOSTICS ULTRACHEM CREA 07/14/1982
K923039 HERAEUS KULZER, INC. MILES URINE CREATININE METHOD 08/24/1992
K791688 HI CHEM, INC. ALKALINE BUFFER 09/17/1979
K782094 HI CHEM, INC. HILAR 01/17/1979
K791689 HI CHEM, INC. PICRIC SOLUTION 09/17/1979
K890671 HICHEM DIAGNOSTICS HI CHEM CREATININE REAGENT (PRODUCT #88809) 05/09/1989
K823573 HOFFMANN-LA ROCHE, INC. COBAS REAGENT FOR CREATININE 01/07/1983
K823572 HOFFMANN-LA ROCHE, INC. COBAS STANDARDS FOR CREATININE 01/07/1983
K072115 HORIBA ABX ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H 11/30/2007
K110530 HORIBA ABX S.A.S. ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL 04/30/2012
K770643 HYCEL, INC. CREATININE TEST, SUPER SEVENTEEN 06/24/1977
K770454 ICN PHARMACEUTICALS, INC. CREATININE PROCEDURE, TEKPOINT 05/03/1977
K771443 INSTRUMENTATION LABORATORY CO. MULTISTAT III CREATININE TEST 08/22/1977
K983937 INTERSECT SYSTEMS, INC. DUAL VIAL CREATININE REAGENT 01/06/1999
K863079 J. D. ASSOC. CREATINKINETIC 12/12/1986
K790044 J.T. BAKER CHEMICAL CO. REAGENT KIT, BAKERS DIAGNOSTIC 02/22/1979
K003247 JAS Diagnostics, Inc. CREATININE 12/14/2000
K811664 KING DIAGNOSTICS, INC. CREATININE TEST 06/25/1981
K844024 LIVONIA DIAGNOSTICS, INC. CREATININE REAGENT SET 10/30/1984
K123586 MEDICA CORPORATION EASYRA CREATININE REAGENT 05/15/2013
K851849 MEDICAL ANALYSIS SYSTEMS, INC. CREATINE LIQUID STABLE REAGENT SET 05/20/1985
K820075 MILES LABORATORIES, INC. SERALYZER CREATININE REAGENT STRIPS 01/26/1982
K945655 MILES, INC. CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO DIAGNOSTIC TEST SYSTEM) 01/05/1995
K781396 NOBEL SCIENTIFIC INDUSTRIES, INC. CREATININE REAGENT SET 09/14/1978
K800583 NOBEL SCIENTIFIC INDUSTRIES, INC. NSI CREATININE KIT 04/02/1980
K901298 OLYMPUS CORP. CREATININE REAGENT FOR AU5000 CLIN LAB ANAL-MODIFY 04/25/1990
K910147 OLYMPUS CORP. CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED 03/11/1991
K923526 OLYMPUS CORP. OLYMPUS CREATININE REAGENT 09/18/1992
K924692 OLYMPUS CORP. OLYMPUS CREATININE REAGENT 10/19/1992
K931939 OLYMPUS CORP. OLYMPUS CREATININE REAGENT 09/21/1993
K934361 OLYMPUS CORP. OLYMPUS CREATININE REAGENT 11/16/1993
K821199 OMEGA MEDICAL ELECTRONICS CREATININE REAGENT SET 07/13/1982
K001769 ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CREA DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT 06/21/2000
K002156 OSBORN GROUP, INC. APPRAISE URINE MICROALBUMIN COLLECTION KIT 12/19/2000
K802156 PANMED, INC. REAGENTS SERUM CREATINE USING TECHICON 10/10/1980
K830556 POINTE SCIENTIFIC, INC. CREATININE 03/24/1983
K893582 PPR DIAGNOSTICS LTD. N-A-G TEST KIT 10/01/1990
K943005 PRISMA SYSTEMS CREATININE QVET 11/22/1994
K973993 RANDOX LABORATORIES, LTD. RANDOX CREATININE 03/06/1998
K840872 REAGENTS APPLICATIONS, INC. RAICHEM CREATININE REAGENT 04/18/1984
K951595 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES 09/08/1995
K902561 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE COBAS READY CREATININE REAGENT 09/07/1990
K941837 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE REAGENT FOR CREATININE 08/26/1994
K895847 SCLAVO, INC. CREATININE 340 (ENZYMATIC) 10/30/1989
K843179 SCLAVO, INC. CREATININE TEST 09/07/1984
K803087 SHERWOOD MEDICAL CO. LANCER CREATININE MICROSAMPLE STAT ANA 01/02/1981
K132638 Siemens Healthcare Diagnostics Inc. DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE 01/27/2014
K133728 Siemens Healthcare Diagnostics Inc. DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE 01/24/2014
K161494 Siemens Healthcare Diagnostics, Inc. Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) 11/15/2016
K771916 SIGMA CHEMICAL CO. PROCEDURE NO. 555 10/19/1977
K933697 SIGMA CHEMICAL CO. SIGMA CRE REAGENT 10/18/1993
K873365 SIGMA DIAGNOSTICS, INC. CREATININE REAGENT 10/02/1987
K963534 SIGMA DIAGNOSTICS, INC. SIGMA DIAGNOSTICS CREATININE REAGENT KIT 09/30/1996
K972743 SIGMA DIAGNOSTICS, INC. SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT 09/22/1997
K873725 SIMMLER, INC. MULTICHEM CREATININE REAGENT S0917 10/20/1987
K954266 SOLARCARE TECHNOLOGIES CORP,INC. STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY 10/13/1995
K771856 STANBIO LABORATORY DIR. QUANT. COLOR. DETERM. SERUM CREAT. 11/03/1977
K860418 STERLING DIAGNOSTICS, INC. CREATININE REAGENT SET 02/11/1986
K974909 SYNERMED INTL., INC. SYNERMED CREATININE REAGENT KIT 02/24/1998
K943924 SYNERMED, INC. CREATININE-PO REAGENT KIT 09/20/1994
K903296 SYNERMED, INC. SYNERMED CREATININE REAGENT KIT 08/17/1990
K926511 SYNERMED, INC. SYNERMED SINGLE REAGENT CREATININE KIT 02/18/1993
K880629 TECH-CO, INC. CREATININE 03/23/1988
K880843 TECH-NEAL SCIENTIFIC, INC. CREATININE REAGENT SET (KINETIC) 04/05/1988
K901229 TECHNICON INSTRUMENTS CORP. CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE) 05/04/1990
K852565 TECHNICON INSTRUMENTS CORP. TECHNICON CHEMI 07/12/1985
K855193 TECHNOSTICS INTL. CREATININE REAGENT SET 01/14/1986
K872310 THE KENDAL CO. CURAD MEDICATED PLASTIC STRIPS 08/28/1987
K870366 TRACE SCIENTIFIC LTD. CREATININE REAGENT - PICRIC ACID METHOD 08/19/1987
K792402 VOLU SOL MEDICAL INDUSTRIES ELVI CREATININ 12/07/1979
K792397 VOLU SOL MEDICAL INDUSTRIES ELVI CREATININE 12/07/1979
K792404 VOLU SOL MEDICAL INDUSTRIES ELVI CREATININE 12/07/1979


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