FDA 510(k) Applications for Medical Device Product Code "CGS"
(Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes)

FDA 510(k) Number Applicant Device Name Decision Date
K890540 ABBOTT LABORATORIES ABBOTT CLINICAL CHEMISTRY REAGENT CK-NAC 02/27/1989
K983070 ABBOTT LABORATORIES CK 02/16/1999
K981218 ABBOTT LABORATORIES CREATINE KINASE (CK) 05/01/1998
K883946 ABBOTT LABORATORIES VISION CREATINE KINASE 10/13/1988
K852000 ALPKEM CORP. CK-NAC REAGENT 05/30/1985
K840783 AMERICAN DADE CREATINE KINASE MB REAGENT 04/04/1984
K831537 AMERICAN DADE PARAMAX CREATINE KINASE REAGENT 06/22/1983
K833781 AMERICAN MONITOR CORP. DURAZYME CPK 01/18/1984
K883504 AMERICAN MONITOR CORP. DURAZYME(R) CPK 09/13/1988
K904004 AMRESCO, INC. AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116 12/11/1990
K903775 AMRESCO, INC. CREATINE PHOSPHOKINASE 10/04/1990
K051648 ARKRAY, INC. SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS 01/31/2006
K781149 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC CPK-L TUBE 08/14/1978
K893269 BECKMAN INSTRUMENTS, INC. BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME 07/20/1989
K821240 BECKMAN INSTRUMENTS, INC. LIQUID-STAT LIQUID ENZYME REAGENT 05/21/1982
K904102 BOEHRINGER MANNHEIM CORP. REFLOTRON CREATINE KINASE TEST TABS 09/27/1990
K971396 CAROLINA LIQUID CHEMISTRIES CORP. CK REAGENT 05/29/1997
K894715 CATACHEM, INC. CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS 11/08/1989
K901267 COULTER CORP. COULTER CK (CREATINE KINASE) REAGENT 05/23/1990
K980900 CRESTAT DIAGNOSTICS, INC. N-ASSAY CPK-L 03/26/1998
K863587 DATA MEDICAL ASSOCIATES, INC. CREATINE PHOSPHOKINASE(CK) PROCEDURE 10/03/1986
K861665 DATA MEDICAL ASSOCIATES, INC. CREATINE PHROSPHOKINASE (CK) PROCEDURE 06/05/1986
K942773 DIAGNOSTIC CHEMICALS LTD. CK-MB ASSAY, CATALOGUE NUMBER 317-10 08/24/1994
K973999 DIAGNOSTIC CHEMICALS LTD. CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30 03/11/1998
K842508 DIAGNOSTIC CHEMICALS, LTD. (USA) CREATINE KINASE ASSAY KIT NAC 07/20/1984
K893691 DIAGNOSTIC SYSTEMS EMDS CREATINE KINASE ITEM NIMBER 65411 08/31/1989
K012474 ELAN HOLDINGS, INC. ATAC PAK CPK REAGENT KIT 10/03/2001
K962247 ELAN PHARMA, INC. HICHEM CK/NAC REAGENT KIT 08/15/1996
K831965 ELECTRO-NUCLEONICS LABORATORIES, INC. CREATINE KINASE REAGENT CK LTS 09/12/1983
K924704 EM DIAGNOSTIC SYSTEMS, INC. CREATINE KINASE (CK) TEST ITEM #65411 10/13/1992
K914361 EM DIAGNOSTIC SYSTEMS, INC. CREATINE KINASE MB TEST ITEM NUMBER 5A46 12/13/1991
K931889 EM DIAGNOSTIC SYSTEMS, INC. CREATINE KINASE TEST 07/27/1993
K903333 EM DIAGNOSTIC SYSTEMS, INC. CREATINE KINASE TEST (CK) ITEM NUMBER 65411 08/17/1990
K884546 EM DIAGNOSTIC SYSTEMS, INC. CREATINE KINASE TEST (CK) ITEM NUMBER: 65661 02/02/1989
K860669 EM DIAGNOSTIC SYSTEMS, INC. CREATINE KINASE, N-ACETYL-L-CYSTIENE 04/07/1986
K884547 EM DIAGNOSTIC SYSTEMS, INC. CREATINE KINASE-MB TEST (CK-MK) ITEM NUMBER 65673 02/10/1989
K902483 EM DIAGNOSTIC SYSTEMS, INC. CREATINE KINASE-MB TEST (MB-DS) ITEM #67655 07/10/1990
K870461 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST CREATINE KINASE (CK) NUMBER: 16614 03/06/1987
K870462 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST CREATINE KINASE-MB (CK-MB) #16615 03/10/1987
K861061 EM DIAGNOSTIC SYSTEMS, INC. EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK 04/24/1986
K855056 EM DIAGNOSTIC SYSTEMS, INC. EMDS TOTAL CK TEST PACK-#67670/95 01/22/1986
K852483 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205 07/12/1985
K843271 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE CK-TOTAL - 67206 09/07/1984
K821464 EMD CHEMICALS INC. CARDIOZYME PLUS CK-MB, #65045 06/02/1982
K821460 EMD CHEMICALS INC. ULTRAZYME PLUS CK-I, #64978,65027&65028 06/01/1982
K821473 EMD CHEMICALS INC. ULTRAZYME PLUS CKI, #64978,65027&65028 06/03/1982
K792477 GENERAL DIAGNOSTICS CHEM-STRATE CK-NAC 12/27/1979
K803301 GILFORD DIAGNOSTICS CREATINE KINASE REAGENT 01/16/1981
K811574 HARLECO CARDIOZYME PLUS CK-TOTAL ITEM #65046 06/25/1981
K811576 HARLECO CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A) 06/25/1981
K771389 HARLECO CK-1 ULTRAZYME PLUS 09/02/1977
K772258 HARLECO CLINICARD CK-II 01/05/1978
K812593 HARLECO ULTRA ZYME PLUS CK-1 #64978, 65027 & 28 10/02/1981
K780100 HARLECO ULTRAZYME PLUS CK-1 03/09/1978
K770694 HARLECO DIAGNOSTICS CPK ULTRAZYME PLUS 07/01/1977
K821883 HARLECO DIAGNOSTICS ULTRAZYME PLUS CK-I 07/14/1982
K852392 HELENA LABORATORIES EDC/TITAN GELISO-TOTAL CPK ISOENZYME PROCEDURE 10/22/1985
K925801 HELENA LABORATORIES REP E-Z CK-30 ISOENZYME KIT 12/28/1992
K893007 HELENA LABORATORIES REP(TM) CK-2 STAT KIT, CAT. NO. 3074 07/20/1989
K842755 HELENA LABORATORIES TITAN GEL ISO DOT CPK PROCEDURE 09/28/1984
K874146 HELENA LABORATORIES TITAN GEL REP CPK-12 HV 11/05/1987
K874139 HELENA LABORATORIES TITAN GEL REP CPK-30 HV 11/03/1987
K874140 HELENA LABORATORIES TITAN GEL REP SIMULTANEOUS CK-LD ISOENZYME PROCED. 11/03/1987
K861879 HI CHEM, INC. CK REAGENT CARTRIDGE (PRODUCT NO. 88213) 05/29/1986
K062737 HORIBA ABX CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER 06/12/2007
K971566 HORIZON DIAGNOSTICS, INC. CREATINE KINASE-MB REAGENT SET 07/14/1997
K770319 ICN PHARMACEUTICALS, INC. REAGENT CPK, ENZYME 04/05/1977
K952646 INSTRUMENTATION LABORATORY CO. IL TEST CK-MB 08/04/1995
K771441 INSTRUMENTATION LABORATORY CO. MULTISTAT III CPK TEST 08/22/1977
K974833 INTERSECT SYSTEMS, INC. CK-NAC REAGENT 02/13/1998
K890609 INTL. IMMUNOASSAY LABORATORIES, INC. IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE) 03/16/1989
K761344 J.T. BAKER CHEMICAL CO. DYNAZYME-II TM CK-230 KIT 01/05/1977
K013912 JAS Diagnostics, Inc. CREATINE KINASE (CK-NAC) 01/18/2002
K931326 KING DIAGNOSTICS, INC. KING DIAGNOSTICS CK REAGENT 06/15/1993
K771849 MALLINCKRODT CRITICAL CARE CPK COLOR TEST KIT 11/03/1977
K780070 MEDICAL ANALYSIS SYSTEMS, INC. CPK REAGENT SET 02/13/1978
K781719 MEDICAL ANALYSIS SYSTEMS, INC. CPK REAGENT SET, NAD REDUCTION 11/03/1978
K952745 MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. CREATINE KINASE REAGENT SYSTEM 08/11/1995
K820880 MILES LABORATORIES, INC. SERALYZER CK REAGENT STRIPS 04/16/1982
K992148 MORAX HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT 12/29/1999
K043202 OLYMPUS AMERICA, INC. OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 12/23/2004
K922459 OLYMPUS CORP. OLYMPUS CREATINE KINASE REAGENT 07/13/1992
K924832 OLYMPUS CORP. OLYMPUS CREATINE KINASE REAGENT 01/04/1993
K994189 OLYMPUS DIAGNOSTICA GMBH OLYMPUS CREATINE KINASE REAGENT OSR6179/6279 01/20/2000
K933675 PB DIAGNOSTIC SYSTEMS, INC. OPUS TOTAL CK 09/08/1993
K930660 POINTE SCIENTIFIC, INC. CREATINE KINASE (CK) REAGENT SET 03/29/1993
K935463 POINTE SCIENTIFIC, INC. CREATINE KINASE-MB (CK-MB) REAGENT SET 01/11/1994
K950177 PRISMA SYSTEMS CK QVET 03/03/1995
K951223 RANDOX LABORATORIES, LTD. CK-MB (NAC-ACT) 12/26/1995
K923511 RANDOX LABORATORIES, LTD. CK-NAC ACTIVATED KIT 10/15/1992
K123977 RANDOX LABORATORIES, LTD. RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR 11/21/2013
K905084 REAGENTS APPLICATIONS, INC. RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV 12/20/1990
K820644 REAGENTS APPLICATIONS, INC. RAICHEM TM CREATINE KINASE REAGENT 04/01/1982
K913398 REAGENTS APPLICATIONS, INC. RAICHEM(TM) CREATINE KINASE-MB REAGENT 09/25/1991
K801299 ROCHE ANALYTICAL INSTRUMENTS, INC. COBAS CK-NAC REAGENT 07/14/1980
K834502 ROCHE DIAGNOSTIC SYSTEMS, INC. CK-NAC REAGENT 02/27/1984
K891462 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE(R) CARDIOSCREEN-CK 05/22/1989
K780311 SCLAVO, INC. DIAGNOSTIC KIT, CPK 04/05/1978
K850212 SCLAVO, INC. ISOENZYME TEST CK-MB 02/07/1985
K873134 SCLAVO, INC. UNIFAST CK-MB 09/16/1987
K081731 SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32 08/29/2008
K083465 SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE 02/27/2009
K160724 SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator 09/07/2016
K781859 SIGMA CHEMICAL CO. REAGENT SYSTEM, NO 46-OV FOR CPK 12/04/1978
K842013 SIGMA CHEMICAL CO. SIGMA PROCEDURE 47-UV 06/25/1984
K854501 SIGMA DIAGNOSTICS, INC. CK(OPTIMIZED) REAGENT 12/04/1985
K972155 STANBIO LABORATORY CREATINE KINASE (CK) 07/17/1997
K860096 STERLING DIAGNOSTICS, INC. CPK REAGENT SET (COLORIMETRIC) 02/11/1986
K930932 SYNERMED, INC. SYNERMED CREATINE KINASE REAGENT KIT 05/11/1993
K915709 TECH INTL. CO. CREATINE KINASE-MB (CK-MB) REAGENT SET 01/27/1992
K864744 TECH-CO, INC. CREATINE PHOSPHOKINASE (CK) 01/13/1987
K772352 TECHNICON INSTRUMENTS CORP. STAC SYSTEM - ADDITIONAL ANALYTES 01/31/1978
K072548 TECO DIAGNOSTICS CREATINE KINASE LIQUID REAGENT, MODEL C519-440 04/18/2008
K810853 THE UPJOHN CO. CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT 05/29/1981
K891470 TRACE SCIENTIFIC LTD. CK-NAC 2-VIAL REAGENT W/SUBSTRATE START 05/09/1989
K860733 TRACE SCIENTIFIC LTD. CK-NAC REAGENT CREATINE KINASE N-ACETYL CYSTEINE 04/24/1986
K864359 TRACE SCIENTIFIC LTD. CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE) 02/06/1987
K800127 UNION CARBIDE CORP. CENTRIFICHEM CK 02/13/1980
K112416 VITAL DIAGNOSTICS (MANUFACTURING) PTYLTD CPK REAGENT 11/09/2011
K873201 WAKO CHEMICALS, USA, INC. WAKO(TM) AUTOKIT CK-NAC 11/05/1987
K021332 WIENER LABORATORIES S.A.I.C. WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA 07/03/2002


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