FDA 510(k) Applications for Medical Device Product Code "CIT"
(Nadh Oxidation/Nad Reduction, Ast/Sgot)

FDA 510(k) Number Applicant Device Name Decision Date
K991663 A.P. TOTAL CARE, INC. AST/SGOT 06/30/1999
K894180 ABBOTT LABORATORIES ABBOTT AST-ACTIVATED (LIQUID, LIST#01A54) 09/13/1989
K071525 ABBOTT LABORATORIES ACTIVATED ASPARTATE AMINOTRANSFERASE 03/19/2008
K981225 ABBOTT LABORATORIES ASPARTATE AMINOTRANSFERASE (AST) 04/23/1998
K981221 ABBOTT LABORATORIES ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED) 04/23/1998
K983131 ABBOTT LABORATORIES AST 09/28/1998
K981843 ABBOTT LABORATORIES AST 06/29/1998
K854982 ABBOTT LABORATORIES VISION SGOT (AST) 01/14/1986
K860465 ABBOTT LABORATORIES VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM 05/05/1986
K852783 ADVANCED BIOMEDICAL METHODS, INC. SGOT/ALT REAGENT 07/22/1985
K851994 ALPKEM CORP. AST ASPARTATE AMINOTRANSFERASE REAGENT 06/03/1985
K840706 AMERICAN DADE ASPARTATE AMINOTRANSFERASE REAGENT 04/04/1984
K792208 AMERICAN MONITOR CORP. "DURAZYME GOT/AST" 11/27/1979
K896000 AMERICAN MONITOR CORP. ASPARTATE AMINOTRANFERASE (AST) 01/11/1990
K800116 AMERICAN MONITOR CORP. DURAZYME GOT/AST 02/13/1980
K791679 AMERICAN MONITOR CORP. NADH OXIDATION, AST/SGOT 09/24/1979
K780443 AMERICAN MONITOR CORP. SGOT/AST REAGENT SYSTEM 04/24/1978
K851865 AMRESCO, INC. AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE 05/20/1985
K903829 AMRESCO, INC. AST REAGENT 09/25/1990
K830958 AMRESCO, INC. FLOW-PAC SGOT REAGENT 05/04/1983
K901104 BAXTER HEALTHCARE CORP. PARAMAX ASPARTATE AMINOTRANSFERASE REAGENT 03/23/1990
K992136 BAYER CORP. BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) 11/09/1999
K780039 BECKMAN INSTRUMENTS, INC. ASPARTATE TRANSAMINASE 01/31/1978
K821433 BECKMAN INSTRUMENTS, INC. BECKMAN LIQUID-STAT AST-UV LIQUID 06/02/1982
K871780 BIOCHEMICAL TRADE, INC. ULTRAVIOLET ASPARTATE AMINO-TRANS (UV-AST/UV-GOT) 06/04/1987
K822493 BIORENT DIAGNOSTIC, INC. OPTIMIZED UV-GOT REAGENT SET 09/21/1982
K872829 BIOTROL, USA, INC. BIOTROL AST/TGO MONOREACTIF 08/13/1987
K810390 BOEHRINGER MANNHEIM CORP. AST (UV) TEST 02/23/1981
K870246 BOEHRINGER MANNHEIM CORP. REFLOTRON(R) AST (GOT) 02/18/1987
K780634 BOEHRINGER MANNHEIM CORP. SINGLE VIAL 10 SGOT-TRIS 05/18/1978
K990009 CARESIDE, INC. CARESIDE AST 03/16/1999
K971344 CAROLINA LIQUID CHEMISTRIES CORP. AST OR SGOT 04/21/1997
K884724 CATACHEM, INC. ASPARTATE AMINOTRANSFERASE (AST) 03/08/1989
K870077 CATACHEM, INC. ASPARTATE AMINOTRANSFERASE (AST)/(GOT) 03/06/1987
K790483 COULTER ELECTRONICS, INC. "COULTER ACCU-ZYME II GOT REAGENT" 05/03/1979
K897165 COULTER ELECTRONICS, INC. COULTER AST (GOT) REAGENT 02/23/1990
K905771 COULTER ELECTRONICS, INC. COULTER DART AST (GOT) REAGENT 02/26/1991
K760193 COULTER ELECTRONICS, INC. NDC#12739-0011-1 C-ZYME GOT 08/03/1976
K980902 CRESTAT DIAGNOSTICS, INC. N-ASSAY L AST/GOT 03/26/1998
K861656 DATA MEDICAL ASSOCIATES, INC. AST/GOT PROCEDURE 05/29/1986
K863257 DATA MEDICAL ASSOCIATES, INC. AST/GOT PROCEDURE 09/26/1986
K801856 DATA MEDICAL ASSOCIATES, INC. DATA-ZYME AST(GOT) PROCEDURE 09/16/1980
K965126 DERMA MEDIA LAB., INC. AST/SGOT 01/17/1997
K974001 DIAGNOSTIC CHEMICALS LTD. ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30 11/13/1997
K842245 DIAGNOSTIC CHEMICALS, LTD. (USA) ASPARTATE AMINOTRANSFERASE ASSAY KIT 07/18/1984
K880692 DIAGNOSTIC CHEMICALS, LTD. (USA) ASPARTATE AMINOTRANSFERASE ASSAY KIT (IFCC) 05/27/1988
K862832 DIAGNOSTIC CHEMICALS, LTD. (USA) MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT 08/12/1986
K800688 DIAGNOSTIC SOLUTIONS, INC. REAGENT FOR DETERM. GLUTAMIC-OXALOACETIC 05/28/1980
K893692 DIAGNOSTIC SYSTEMS EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405 08/21/1989
K080485 DIASYS DIAGNOSTICS SYSTEMS GMBH ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS 12/04/2008
K934413 EASTMAN KODAK COMPANY KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ASPARATE AMIMOTRANSFERASE 04/25/1994
K010488 ELAN HOLDINGS, INC. ATAC PAK AST REAGENT KIT 04/09/2001
K851267 ELECTRO-NUCLEONICS LABORATORIES, INC. GEMENI AST-LTS REAGENTS 04/29/1985
K914068 EM DIAGNOSTIC SYSTEMS, INC. ABBOTT QUICKSTART ASPARATE AMINOTRANSFERASE TEST 10/02/1991
K914463 EM DIAGNOSTIC SYSTEMS, INC. ABBOTT QUICKSTART SGOT, ITEM NUMBER: 5A42 01/03/1992
K935181 EM DIAGNOSTIC SYSTEMS, INC. ASPARTATE AMINOTRANSFERASE (AST) TEST 01/27/1994
K903197 EM DIAGNOSTIC SYSTEMS, INC. ASPARTATE AMINOTRANSFERASE TEST 08/17/1990
K884377 EM DIAGNOSTIC SYSTEMS, INC. ASPARTATE AMINOTRANSFERASE TEST ITEM NO. 65654 12/14/1988
K874600 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010 01/21/1988
K863963 EM DIAGNOSTIC SYSTEMS, INC. EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95 11/28/1986
K922857 EM DIAGNOSTIC SYSTEMS, INC. SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICO 09/09/1992
K863094 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE (TM) ALANINE TRANSFERASE (ALT) 08/29/1986
K843333 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE GOT 67208 09/20/1984
K821467 EMD CHEMICALS INC. ULTRAZYME PLUS GOT, #64953,65033&65034 06/01/1982
K790017 FISHER SCIENTIFIC CO., LLC. SERUM, GLUTAMIC-OXALOACETIC 02/26/1979
K780505 GAMMA ENTERPRISES, INC. SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE 05/03/1978
K800065 GILFORD DIAGNOSTICS ASI REAGENT 02/05/1980
K781784 GILFORD DIAGNOSTICS AST 01/03/1979
K772029 HARLECO GEMSAEC APPLI, FOR ULTRAZYME PLUS GOT 11/15/1977
K812592 HARLECO ULTRA ZYME PLUS GOT #64953, 65033 & 34 09/24/1981
K780103 HARLECO ULTRAZYME PLUS GOT 02/13/1978
K821876 HARLECO DIAGNOSTICS ULTRAZYME PLUS GOT 07/13/1982
K885156 HERAEUS KULZER, INC. CLINISTAT SGOT (AST) REAGENT TEST 02/02/1989
K920336 HERAEUS KULZER, INC. MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD 03/04/1992
K861283 HI CHEM, INC. AST REAGENT CARTRIDGE 04/28/1986
K951751 HICHEM DIAGNOSTICS HICHEM AST REAGENT KIT 08/02/1995
K060318 HORIBA ABX HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER 08/08/2006
K770318 ICN PHARMACEUTICALS, INC. REAGENT GOT, ENZYME 04/05/1977
K923641 INSTRUMENTATION LABORATORY CO. IL TEST AST, PN 35312 10/26/1992
K863054 J. D. ASSOC. AST S.C.E. (GOT) 01/13/1987
K771153 J.T. BAKER CHEMICAL CO. DYNA ZYME II GOT 340 11/03/1977
K013698 JAS Diagnostics, Inc. AST (SGOT) 12/21/2001
K922108 KING DIAGNOSTICS, INC. KING DIAGNOSTICS AST (GOT) REAGENT 07/15/1992
K780013 MACOMB CHEMICAL CO. SERUM GLUTAMIC OXALOACETIC TRANSAMINASE 01/30/1978
K781725 MEDICAL ANALYSIS SYSTEMS, INC. REAGENT SET, U.V. ENZMATIC KINETIC, SGOT 11/03/1978
K952743 MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM 09/29/1995
K841066 MEDICAL SPECIALTIES, INC. SGOT-UV REAGENT SET 05/01/1984
K922885 OLYMPUS CORP. OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT 07/28/1992
K925155 OLYMPUS CORP. OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT 01/26/1993
K821208 OMEGA MEDICAL ELECTRONICS SGOT-UV REAGENT SET 07/20/1982
K001679 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3 06/28/2000
K813405 POINTE SCIENTIFIC, INC. AST(SGOT) IN VITRO DIAG. REAGENT SET 12/22/1981
K941132 POINTE SCIENTIFIC, INC. LIQUID AST (SGOT)REAGENT SET 05/02/1994
K944102 PRISMA SYSTEMS AST QVET 12/13/1994
K923505 RANDOX LABORATORIES, LTD. AST (GOT) - ASPARTATE AMINOTRANSFERASE 11/16/1992
K820270 REAGENTS APPLICATIONS, INC. RAICHEM GOT (AST) REAGENT 02/18/1982
K801118 ROCHE ANALYTICAL INSTRUMENTS, INC. COBAS REAGENT FOR AST (SGOT) 06/20/1980
K896228 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS READY CARDIO PROFILE REAGENT STRIP 02/16/1990
K896233 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS READY LIVER PROFILE REAGENT STRIP 02/16/1990
K896229 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS READY PROFILE 1 REAGENT STRIP 02/16/1990
K954992 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE COBAS INTEGRA REAGENT CASSETTES 01/25/1996
K843109 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE REAGENT FOR AST 11/05/1984
K924244 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE REAGENT FOR AST 01/04/1993
K071211 Roche Diagnostics COBAS C 111 ANALYZER 07/30/2007
K780463 SCLAVO, INC. AST(GOT) UNI-UV, SGOT 05/12/1978
K093883 SEPPIM S.A.S. AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT- 09/20/2010
K892844 SIGMA CHEMICAL CO. AST REAGENT (PROCEDURE NUMBER 158) 06/20/1989
K842411 SIGMA CHEMICAL CO. SIGMA 58-UV ASPARTATE AMINOTRANSFERAS 08/12/1984
K954839 SIGMA DIAGNOSTICS, INC. ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV 01/05/1996
K854503 SIGMA DIAGNOSTICS, INC. AST(OPTIMIZED) REAGENT 11/25/1985
K980666 SIGMA DIAGNOSTICS, INC. INFINITY AST REAGENT (PROCEDURE NO. 51) 03/20/1998
K992801 SIGMA DIAGNOSTICS, INC. SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5 09/28/1999
K791080 SMITH KLINE DIAGNOSTICS, INC. PLUS CHEM S.C.E. REAGENT 07/24/1979
K791082 SMITH KLINE DIAGNOSTICS, INC. SPIN CHEM REAGENT, DETERMINATION OF AST 07/17/1979
K932049 STANBIO LABORATORY STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020 11/16/1993
K842521 STERLING BIOCHEMICAL, INC. AST/GOT REAGENT SET UV RATE 08/12/1984
K860667 STERLING DIAGNOSTICS, INC. ASPARTATE AMINOTRANSFERASE (AST/SGOT) REAGENT SET 04/03/1986
K802447 SYN-KIT, INC. GOT ISOENZYME ASSAY EIKEN KIT 04/17/1981
K915555 SYNERMED, INC. SYNERMED AST/GOT REAGENT KIT 01/27/1992
K875071 TECH-CO, INC. ASPARTATE AMINOTRANSFERASE AST/SGOT 02/18/1988
K880276 TECH-NEAL SCIENTIFIC, INC. AST (SGOT) REAGENT SET 03/03/1988
K914025 TECHNICON INSTRUMENTS CORP. TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P) 11/22/1991
K981650 TECO DIAGNOSTICS AST/SGOT LIQUID REAGENT - KINETIC METHOD 06/29/1998
K781020 THE DOW CHEMICAL CO. (AST) OR (ALT) UV DETERM. PHY. PHOS. 07/27/1978
K810727 THE DOW CHEMICAL CO. AST-UV (PLP-ACTIVATED) DETERMINATION 03/31/1981
K760010 THE DOW CHEMICAL CO. COLORIMETRIC DETERMINATION (SGOT/SGPT) 07/26/1976
K071580 THERMO FISHER SCIENTIFIC OY AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL 10/03/2007
K980030 TRACE AMERICA, INC. AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) 01/30/1998
K891468 TRACE SCIENTIFIC LTD. AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT 05/22/1989
K961114 TRACE SCIENTIFIC LTD. AST INCORPORATING DST 05/23/1996
K860725 TRACE SCIENTIFIC LTD. AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT 04/07/1986
K864357 TRACE SCIENTIFIC LTD. AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT 02/06/1987
K800641 UNION CARBIDE CORP. CENTRIFI CHEM AST/SGOT 04/10/1980
K803216 UNION CARBIDE CORP. CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT 01/09/1981
K864813 WAKO CHEMICALS, USA, INC. WAKO (TM) AUTOKIT GOT TEST 02/13/1987
K993468 WAKO CHEMICALS, USA, INC. WAKO L-TYPE GOT TEST 12/16/1999
K864302 WAKO CHEMICALS, USA, INC. WAKO(TM) GOT II - HA 12/16/1986
K023551 WIENER LABORATORIES S.A.I.C. WIENER LAB GOT (AST) UV AA LIQUIDA 12/09/2002
K013145 WIENER LABORATORIES S.A.I.C. WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR. 11/27/2001


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