Atlas FDA

CIT

139 FDA 510(k) clearances · Product code

46 daysmedian time to decision
117 days90th percentile
139clearances measured

FDA profile

Official device name
Nadh Oxidation/Nad Reduction, Ast/Sgot
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1100
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2004: 2 · 2007: 23 · 2008: 17 · 2011: 7
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
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- (K093883)Seppim S.A.S.2010-09-20
ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS (K080485)Diasys Diagnostics Systems GmbH2008-12-04
ACTIVATED ASPARTATE AMINOTRANSFERASE (K071525)Abbott Laboratories2008-03-19
AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL (K071580)Thermofisher Scientific OY2007-10-03
COBAS C 111 ANALYZER (K071211)Roche Diagnostics2007-07-30
HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (K060318)Horiba Abx2006-08-08
WIENER LAB GOT (AST) UV AA LIQUIDA (K023551)Wiener Laboratories Saic2002-12-09
AST (SGOT) (K013698)Jas Diagnostics, Inc.2001-12-21
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. (K013145)Wiener Laboratories Saic2001-11-27
ATAC PAK AST REAGENT KIT (K010488)Elan Holdings, Inc.2001-04-09
VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3 (K001679)Ortho-Clinical Diagnostics, Inc.2000-06-28
WAKO L-TYPE GOT TEST (K993468)Wako Chemicals USA, Inc.1999-12-16
BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) (K992136)Bayer Corp.1999-11-09
SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5 (K992801)Sigma Diagnostics, Inc.1999-09-28
AST/SGOT (K991663)A.P. Total Care, Inc.1999-06-30
CARESIDE AST (K990009)Careside, Inc.1999-03-16
AST (K983131)Abbott Laboratories1998-09-28
AST/SGOT LIQUID REAGENT - KINETIC METHOD (K981650)Teco Diagnostics1998-06-29
AST (K981843)Abbott Laboratories1998-06-29
ASPARTATE AMINOTRANSFERASE (AST) (K981225)Abbott Laboratories1998-04-23
ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED) (K981221)Abbott Laboratories1998-04-23
N-ASSAY L AST/GOT (K980902)Crestat Diagnostics, Inc.1998-03-26
INFINITY AST REAGENT (PROCEDURE NO. 51) (K980666)Sigma Diagnostics, Inc.1998-03-20
AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (K980030)Trace America, Inc.1998-01-30
ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30 (K974001)Diagnostic Chemicals , Ltd.1997-11-13
AST OR SGOT (K971344)Carolina Liquid Chemistries Corp.1997-04-21
AST/SGOT (K965126)Derma Media Lab., Inc.1997-01-17
AST INCORPORATING DST (K961114)Trace Scientific , Ltd.1996-05-23
ROCHE COBAS INTEGRA REAGENT CASSETTES (K954992)Roche Diagnostic Systems, Inc.1996-01-25
ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV (K954839)Sigma Diagnostics, Inc.1996-01-05
ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM (K952743)Medical Diagnostic Technologies, Inc.1995-09-29
HICHEM AST REAGENT KIT (K951751)Hichem Diagnostics1995-08-02
AST QVET (K944102)Prisma Systems1994-12-13
LIQUID AST (SGOT)REAGENT SET (K941132)Pointe Scientific, Inc.,1994-05-02
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ASPARATE AMIMOTRANSFERASE (K934413)Eastman Kodak Company1994-04-25
ASPARTATE AMINOTRANSFERASE (AST) TEST (K935181)Em Diagnostic Systems, Inc.1994-01-27
STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020 (K932049)Stanbio Laboratory1993-11-16
OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT (K925155)Olympus Corp.1993-01-26
ROCHE REAGENT FOR AST (K924244)Roche Diagnostic Systems, Inc.1993-01-04
AST (GOT) - ASPARTATE AMINOTRANSFERASE (K923505)Randox Laboratories, Ltd.1992-11-16
IL TEST AST, PN 35312 (K923641)Instrumentation Laboratory CO1992-10-26
SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICO (K922857)Em Diagnostic Systems, Inc.1992-09-09
OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT (K922885)Olympus Corp.1992-07-28
KING DIAGNOSTICS AST (GOT) REAGENT (K922108)King Diagnostics, Inc.1992-07-15
MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD (K920336)Heraeus Kulzer, Inc.1992-03-04
SYNERMED AST/GOT REAGENT KIT (K915555)Synermed, Inc.1992-01-27
ABBOTT QUICKSTART SGOT, ITEM NUMBER: 5A42 (K914463)Em Diagnostic Systems, Inc.1992-01-03
TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P) (K914025)Technicon Instruments Corp.1991-11-22
ABBOTT QUICKSTART ASPARATE AMINOTRANSFERASE TEST (K914068)Em Diagnostic Systems, Inc.1991-10-02
COULTER DART AST (GOT) REAGENT (K905771)Coulter Electronics, Inc.1991-02-26
AST REAGENT (K903829)Amresco, Inc.1990-09-25
ASPARTATE AMINOTRANSFERASE TEST (K903197)Em Diagnostic Systems, Inc.1990-08-17
PARAMAX ASPARTATE AMINOTRANSFERASE REAGENT (K901104)Baxter Healthcare Corp1990-03-23
COULTER AST (GOT) REAGENT (K897165)Coulter Electronics, Inc.1990-02-23
COBAS READY PROFILE 1 REAGENT STRIP (K896229)Roche Diagnostic Systems, Inc.1990-02-16
COBAS READY CARDIO PROFILE REAGENT STRIP (K896228)Roche Diagnostic Systems, Inc.1990-02-16
COBAS READY LIVER PROFILE REAGENT STRIP (K896233)Roche Diagnostic Systems, Inc.1990-02-16
ASPARTATE AMINOTRANFERASE (AST) (K896000)American Monitor Corp.1990-01-11
ABBOTT AST-ACTIVATED (LIQUID, LIST#01A54) (K894180)Abbott Laboratories1989-09-13
EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405 (K893692)Diagnostic Systems1989-08-21
AST REAGENT (PROCEDURE NUMBER 158) (K892844)Sigma Chemical Co.1989-06-20
AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT (K891468)Trace Scientific , Ltd.1989-05-22
ASPARTATE AMINOTRANSFERASE (AST) (K884724)Catachem, Inc.1989-03-08
CLINISTAT SGOT (AST) REAGENT TEST (K885156)Heraeus Kulzer, Inc.1989-02-02
ASPARTATE AMINOTRANSFERASE TEST ITEM NO. 65654 (K884377)Em Diagnostic Systems, Inc.1988-12-14
ASPARTATE AMINOTRANSFERASE ASSAY KIT (IFCC) (K880692)Diagnostic Chemicals, Ltd. (Usa)1988-05-27
AST (SGOT) REAGENT SET (K880276)Tech-Neal Scientific, Inc.1988-03-03
ASPARTATE AMINOTRANSFERASE AST/SGOT (K875071)Tech-Co, Inc.1988-02-18
EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010 (K874600)Em Diagnostic Systems, Inc.1988-01-21
BIOTROL AST/TGO MONOREACTIF (K872829)Biotrol, USA, Inc.1987-08-13
ULTRAVIOLET ASPARTATE AMINO-TRANS (UV-AST/UV-GOT) (K871780)Biochemical Trade, Inc.1987-06-04
ASPARTATE AMINOTRANSFERASE (AST)/(GOT) (K870077)Catachem, Inc.1987-03-06
REFLOTRON(R) AST (GOT) (K870246)Boehringer Mannheim Corp.1987-02-18
WAKO (TM) AUTOKIT GOT TEST (K864813)Wako Chemicals USA, Inc.1987-02-13
AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT (K864357)Trace Scientific , Ltd.1987-02-06
AST S.C.E. (GOT) (K863054)J. D. Assoc.1987-01-13
WAKO(TM) GOT II - HA (K864302)Wako Chemicals USA, Inc.1986-12-16
EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95 (K863963)Em Diagnostic Systems, Inc.1986-11-28
AST/GOT PROCEDURE (K863257)Data Medical Associates, Inc.1986-09-26
SYSTEMATE (TM) ALANINE TRANSFERASE (ALT) (K863094)Em Diagnostic Systems, Inc.1986-08-29
MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT (K862832)Diagnostic Chemicals, Ltd. (Usa)1986-08-12
AST/GOT PROCEDURE (K861656)Data Medical Associates, Inc.1986-05-29
VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM (K860465)Abbott Laboratories1986-05-05
AST REAGENT CARTRIDGE (K861283)Hi Chem, Inc.1986-04-28
AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT (K860725)Trace Scientific , Ltd.1986-04-07
ASPARTATE AMINOTRANSFERASE (AST/SGOT) REAGENT SET (K860667)Sterling Diagnostics, Inc.1986-04-03
VISION SGOT (AST) (K854982)Abbott Laboratories1986-01-14
AST(OPTIMIZED) REAGENT (K854503)Sigma Diagnostics, Inc.1985-11-25
SGOT/ALT REAGENT (K852783)Advanced Biomedical Methods, Inc.1985-07-22
AST ASPARTATE AMINOTRANSFERASE REAGENT (K851994)Alpkem Corp.1985-06-03
AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE (K851865)Amresco, Inc.1985-05-20
GEMENI AST-LTS REAGENTS (K851267)Electro-Nucleonics Laboratories, Inc.1985-04-29
ROCHE REAGENT FOR AST (K843109)Roche Diagnostic Systems, Inc.1984-11-05
SYSTEMATE GOT 67208 (K843333)Em Diagnostic Systems, Inc.1984-09-20
SIGMA 58-UV ASPARTATE AMINOTRANSFERAS (K842411)Sigma Chemical Co.1984-08-12
AST/GOT REAGENT SET UV RATE (K842521)Sterling Biochemical, Inc.1984-08-12
ASPARTATE AMINOTRANSFERASE ASSAY KIT (K842245)Diagnostic Chemicals, Ltd. (Usa)1984-07-18
SGOT-UV REAGENT SET (K841066)Medical Specialties, Inc.1984-05-01
ASPARTATE AMINOTRANSFERASE REAGENT (K840706)American Dade1984-04-04
FLOW-PAC SGOT REAGENT (K830958)Amresco, Inc.1983-05-04
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