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 |