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 |
| K925155 | OLYMPUS CORP. | OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT | 01/26/1993 |
| K922885 | OLYMPUS CORP. | OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT | 07/28/1992 |
| 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 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
