FDA 510(k) Applications for Medical Device Product Code "CKA"
(Nadh Oxidation/Nad Reduction, Alt/Sgpt)

FDA 510(k) Number Applicant Device Name Decision Date
K890698 ABBOTT LABORATORIES ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55) 04/10/1989
K812926 ABBOTT LABORATORIES ALT-QUANTICHROM 11/06/1981
K861002 ABBOTT LABORATORIES VISION SGPT (ALT) 04/21/1986
K113382 ALFA WASSERMANN ACE ALT REAGENT 07/19/2012
K851995 ALPKEM CORP. ALT (ALANINE AMINO-THRANSFERASE)REAGENT 05/30/1985
K840705 AMERICAN DADE PARAMAX ALANINE AMINOTRANSFERASE 03/09/1984
K896001 AMERICAN MONITOR CORP. ALANINE AMINOTRANSFERASE (ALT) 11/13/1989
K800115 AMERICAN MONITOR CORP. DURAZYME GPT/ALT 02/13/1980
K791641 AMERICAN MONITOR CORP. SGPT REAGENT SET MODIFICATION 09/24/1979
K780791 AMERICAN MONITOR CORP. SGPT/ALT REAGENT SYSTEM 06/13/1978
K901702 AMERICAN RESEARCH PRODUCTS CO. NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522 04/25/1990
K851923 AMRESCO, INC. AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE 05/24/1985
K830959 AMRESCO, INC. FLOW-PAC SGPT REAGENT 05/04/1983
K811694 BAKER INSTRUCTIONS CORP. CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT 07/01/1981
K901105 BAXTER HEALTHCARE CORP. PARAMAX ALANINE AMINOTRANSFERASE REAGENT 03/23/1990
K780040 BECKMAN INSTRUMENTS, INC. ALANINE TRANSAMINASE 01/31/1978
K952427 BECKMAN INSTRUMENTS, INC. CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE 09/21/1995
K821048 BECKMAN INSTRUMENTS, INC. LIQUID-STAT TM AST-UV LIQUID ENZUNE 05/03/1982
K883181 BECKMAN INSTRUMENTS, INC. SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE 09/19/1988
K871782 BIOCHEMICAL TRADE, INC. ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT) 05/26/1987
K822494 BIORENT DIAGNOSTIC, INC. OPTIMIZED UV-GPT REAGENT SET 09/21/1982
K872830 BIOTROL, USA, INC. BIOTROL ALT/TGP MONOREACTIF 08/13/1987
K810355 BOEHRINGER MANNHEIM CORP. ALT (UV) TEST 02/23/1981
K821805 BOEHRINGER MANNHEIM CORP. PYRIDOXAL-5-PHOSPHATE STRIPES 07/02/1982
K874835 BOEHRINGER MANNHEIM CORP. PYRIDOXAL-5-PHOSPHATE TABLETS 01/21/1988
K780636 BOEHRINGER MANNHEIM CORP. SINGLE VIAL 10 SGPT-TRIS 05/18/1978
K861792 BOEHRINGER MANNHEIM CORP. TWIN GOT-AST IFCC/GPT-ALT IFCC 07/29/1986
K020487 CARESIDE, INC. CARESIDE ALT 06/04/2002
K971323 CAROLINA LIQUID CHEMISTRIES CORP. ALT OR SGPT 04/21/1997
K884936 CATACHEM, INC. ALANINE AMINOTRANSFERASE 01/03/1989
K870086 CATACHEM, INC. ALANINE AMINOTRANSFERASE (ALT)/(GPT) 03/06/1987
K854186 CLINICAL DATA, INC. IN VITRO TEST DETERMINATION OF SGPT(ALT) 12/25/1985
K790522 COULTER ELECTRONICS, INC. COULTER ACCU-ZYME II GPT REAGENT 05/01/1979
K897163 COULTER ELECTRONICS, INC. COULTER ALT (GPT) REAGENT 03/09/1990
K905767 COULTER ELECTRONICS, INC. COULTER DART ALT (GPT) REAGENT 01/25/1991
K760194 COULTER ELECTRONICS, INC. NDC#12739-0010-1 C-ZYME GPT 08/03/1976
K061020 DADE BEHRING, INC. DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE 05/10/2006
K951332 DADE INTL., INC. PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT 06/19/1995
K863253 DATA MEDICAL ASSOCIATES, INC. ALT/GPT PROCEDURE 09/16/1986
K861658 DATA MEDICAL ASSOCIATES, INC. ALT/GPT PROCEDURE 05/29/1986
K801857 DATA MEDICAL ASSOCIATES, INC. DATA-ZYME LAT(GPT) PROCEDURE 09/16/1980
K965134 DERMA MEDIA LAB., INC. ALT/SGPT 02/18/1997
K974003 DIAGNOSTIC CHEMICALS LTD. ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30 12/05/1997
K842241 DIAGNOSTIC CHEMICALS, LTD. (USA) ALANINE AMINOTRANSFERASE ASSAY KIT 07/18/1984
K862833 DIAGNOSTIC CHEMICALS, LTD. (USA) MODEL 303-47/303-48 ALANINE AMINOTRANSFERASE KIT 08/19/1986
K800689 DIAGNOSTIC SOLUTIONS, INC. REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- 05/30/1980
K861366 DIMENSION DIAGNOSTICS ALT-30, 60 AND 100 06/25/1986
K832639 ELECTRO-NUCLEONICS LABORATORIES, INC. ALT -LTS 09/12/1983
K761269 ELECTRO-NUCLEONICS LABORATORIES, INC. GEMENI GPT (ALT) ASSAY 12/29/1976
K883205 ELECTRO-NUCLEONICS, INC. ALTLTS ALANINE AMINO TRANSFERASE ALT 09/09/1988
K913846 EM DIAGNOSTIC SYSTEMS, INC. ABBOTT QUICKSTART ALANINE AMINOTRANSFER 09/19/1991
K914464 EM DIAGNOSTIC SYSTEMS, INC. ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43 11/22/1991
K935180 EM DIAGNOSTIC SYSTEMS, INC. ALANINE AMINOTRANSFERASE (ALT) TEST 01/13/1994
K903198 EM DIAGNOSTIC SYSTEMS, INC. ALANINE AMINOTRANSFERASE TEST 09/12/1990
K893752 EM DIAGNOSTIC SYSTEMS, INC. ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403 07/20/1989
K884376 EM DIAGNOSTIC SYSTEMS, INC. ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652 01/11/1989
K874586 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017 01/21/1988
K923257 EM DIAGNOSTIC SYSTEMS, INC. EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000 09/28/1992
K863962 EM DIAGNOSTIC SYSTEMS, INC. EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95 11/28/1986
K843334 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE GPT 67209 09/20/1984
K790016 FISHER SCIENTIFIC CO., LLC. SERUM, GLUTAMIC-PYRUVIC 02/15/1979
K870879 GENETIC SYSTEMS CORP. ALANINE TRANSAMINASE (ALT) TEST KIT 03/19/1987
K800038 GILFORD DIAGNOSTICS ALT REAGENT 01/21/1980
K772030 HARLECO GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT 11/14/1977
K812591 HARLECO ULTRA ZYME PLUS GPT, #64956, 65035 & 36 09/24/1981
K770882 HARLECO ULTRAZYME PLUS GPT 07/14/1977
K780102 HARLECO ULTRAZYME PLUS GPT 02/13/1978
K821882 HARLECO DIAGNOSTICS ULTRAZYME PLUS GPT 07/14/1982
K885144 HERAEUS KULZER, INC. CLINISTAT SGPT (ALT) SERUM GLUTAMATE PYRUVATE TRAN 02/02/1989
K920335 HERAEUS KULZER, INC. MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD 03/24/1992
K861231 HI CHEM, INC. ALT REAGENT CARTRIDGE (PRODUCT NO. 88210) 04/28/1986
K852867 HI CHEM, INC. HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE 08/29/1985
K951818 HI CHEM, INC. HICHEM ALT REAGENT KIT 05/15/1995
K120945 HITACHI CHEMICAL DIAGNOSTICS, INC. HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST 06/07/2013
K770314 ICN PHARMACEUTICALS, INC. REAGENT GPT, ENZYME 03/30/1977
K923623 INSTRUMENTATION LABORATORY CO. IL TEST ALT, PN 35311 09/17/1992
K771466 INSTRUMENTATION LABORATORY CO. MULTISTAT III ALANINE AMINOTRANSFERASE 09/02/1977
K930070 ISOLAB, INC. HEMOCARD HEMOGLOBIN E 04/08/1993
K863053 J. D. ASSOC. ALT S.C.E. (GPT) 12/10/1986
K771152 J.T. BAKER CHEMICAL CO. DYNAZYME II GPT 340 11/03/1977
K922109 KING DIAGNOSTICS, INC. KING DIAGNOSTICS ALT (GPT) REAGENT 06/04/1992
K770991 MACOMB CHEMICAL CO. SERUM GLUTAMIC PYRUVIC TRANSAMINASE 08/02/1977
K781726 MEDICAL ANALYSIS SYSTEMS, INC. REAGENT SET, SGPT SERUM GLUTAMIC 11/03/1978
K952744 MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. ALANINE AMINOTRANSFERASE REAGENT SYSTEM 08/07/1995
K841060 MEDICAL SPECIALTIES, INC. SGPT REAGENT SET 05/01/1984
K771033 MID TECH, INC. SMAC SYS., SUPPLEMENTAL PRODUCTS FOR 08/04/1977
K875079 MILES LABORATORIES, INC. MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE 04/05/1988
K925339 OLYMPUS CORP. OLYLMPUS ALANINE AMINOTRANSFERASE REAGENT 02/05/1993
K922884 OLYMPUS CORP. OLYMPUS ALANINE AMINOTRANSFERASE REAGENT 07/28/1992
K821206 OMEGA MEDICAL ELECTRONICS SGPT-UV REAGENT SET 07/22/1982
K813495 POINTE SCIENTIFIC, INC. ALT (SGPT) 12/31/1981
K941287 POINTE SCIENTIFIC, INC. LIQUID ALT(SGPT) REAGENT SET 05/03/1994
K944080 PRISMA SYSTEMS ALT QVET 11/22/1994
K923510 RANDOX LABORATORIES, LTD. ALT (GPT) - ALANINE AMINOTRANSFERASE 11/16/1992
K820525 REAGENTS APPLICATIONS, INC. RAICHEM GPT (ALT) REAGENT 03/15/1982
K801119 ROCHE ANALYTICAL INSTRUMENTS, INC. COBAS REAGENT FOR ALT (GPT) 06/09/1980
K896234 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS READY STAT PROFILE REAGENT STRIP 02/16/1990
K843111 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE REAGENT FOR ALT 10/05/1984
K924245 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE REAGENT FOR ALT 10/22/1992
K780462 SCLAVO, INC. ALT(GPT) UNI-UV, SGPT 05/12/1978
K893560 SIGMA CHEMICAL CO. ALT REAGENT (PROCEDURE NUMBER 159) 07/20/1989
K842564 SIGMA CHEMICAL CO. SIGMA 59-UV FOR ALANINE AMINOTRANSFER 08/12/1984
K854502 SIGMA DIAGNOSTICS, INC. ALT(OPTIMIZED) REAGENT 11/25/1985
K791084 SMITH KLINE DIAGNOSTICS, INC. PLUS CHEM, DETERMINATION OF ALT (GPT) 07/17/1979
K791083 SMITH KLINE DIAGNOSTICS, INC. SPIN CHEM, DETERMINATION OF ALT (GPT) 07/17/1979
K941497 SOLARCARE, INC. SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY 05/24/1994
K941314 STANBIO LABORATORY STANBIO ALT/GPT (LUQUI-UV) TEST SET 07/20/1994
K844251 STERLING BIOCHEMICAL, INC. ALT/GPT REAGENT SET 01/08/1985
K862209 STERLING DIAGNOSTICS, INC. ALT (SGPT) REAGENT SET (UV RATE) 06/25/1986
K921016 SYNERMED, INC. SYNERMED ALT/GPT REAGENT KIT 05/07/1992
K864906 TECH-CO, INC. ALANINE AMINO TRANSFERASE ALT/SGPT 12/31/1986
K880275 TECH-NEAL SCIENTIFIC, INC. ALT (SGPT) REAGENT SET 03/01/1988
K780373 TECHNICON INSTRUMENTS CORP. STAC SYSTEM 04/28/1978
K900905 TECHNICON INSTRUMENTS CORP. TECHNICON AXON SYSTEM REAGENT METHODS 04/03/1990
K892930 TECHNICON INSTRUMENTS CORP. TECHNICON DAX TM SYSTEM ADDITIONAL ANALYTES 07/27/1989
K820394 TECHNICON INSTRUMENTS CORP. TECHNICON RA-1000 SYSTEM ADD. ANALYT 03/08/1982
K860110 TECHNOSTICS INTL. GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET 02/11/1986
K821536 THE DOW CHEMICAL CO. DOWFLOW ALT-UV DETERMINATION 06/14/1982
K980028 TRACE AMERICA, INC. ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) 02/02/1998
K973869 TRACE AMERICA, INC. TRACE REAGENT LINE FOR THE COBAS MIRA 01/07/1998
K891469 TRACE SCIENTIFIC LTD. ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT 04/04/1989
K961123 TRACE SCIENTIFIC LTD. ALT INCORPORATING DST 04/25/1996
K860727 TRACE SCIENTIFIC LTD. ALT(GPT) (ALANINE AMINOTRANSFERASE) REAGENT 04/07/1986
K872483 TRACE SCIENTIFIC LTD. MODIFIED ALT (GPT) REAGENT 08/19/1987
K821946 TRAVENOL LABORATORIES, S.A. ALT ENZYME ASSAY KIT 07/20/1982
K864335 WAKO CHEMICALS, USA, INC. WAKO GPT II - HA 12/16/1986
K864850 WAKO CHEMICALS, USA, INC. WAKO(TM) AUTOKIT GPT 01/09/1987


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