FDA Product Code
FDA Product Code CIT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1100
510(k) Clearances — 139 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K093883 | 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- | Seppim S.A.S. | 2010-09-20 | Traditional | PDF ↗ |
| K080485 | ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS | Diasys Diagnostics Systems GmbH | 2008-12-04 | Traditional | PDF ↗ |
| K071525 | ACTIVATED ASPARTATE AMINOTRANSFERASE | Abbott Laboratories | 2008-03-19 | Traditional | PDF ↗ |
| K071580 | AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL | Thermofisher Scientific OY | 2007-10-03 | Traditional | PDF ↗ |
| K071211 | COBAS C 111 ANALYZER | Roche Diagnostics | 2007-07-30 | Traditional | PDF ↗ |
| K060318 | HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER | Horiba Abx | 2006-08-08 | Traditional | PDF ↗ |
| K023551 | WIENER LAB GOT (AST) UV AA LIQUIDA | Wiener Laboratories Saic | 2002-12-09 | Traditional | PDF ↗ |
| K013698 | AST (SGOT) | Jas Diagnostics, Inc. | 2001-12-21 | Traditional | PDF ↗ |
| K013145 | 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. | Wiener Laboratories Saic | 2001-11-27 | Traditional | PDF ↗ |
| K010488 | ATAC PAK AST REAGENT KIT | Elan Holdings, Inc. | 2001-04-09 | Traditional | PDF ↗ |
| K001679 | VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3 | Ortho-Clinical Diagnostics, Inc. | 2000-06-28 | Special | PDF ↗ |
| K993468 | WAKO L-TYPE GOT TEST | Wako Chemicals USA, Inc. | 1999-12-16 | Traditional | PDF ↗ |
| K992136 | BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) | Bayer Corp. | 1999-11-09 | Traditional | PDF ↗ |
| K992801 | SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5 | Sigma Diagnostics, Inc. | 1999-09-28 | Traditional | PDF ↗ |
| K991663 | AST/SGOT | A.P. Total Care, Inc. | 1999-06-30 | Traditional | PDF ↗ |
| K990009 | CARESIDE AST | Careside, Inc. | 1999-03-16 | Traditional | PDF ↗ |
| K983131 | AST | Abbott Laboratories | 1998-09-28 | Traditional | PDF ↗ |
| K981650 | AST/SGOT LIQUID REAGENT - KINETIC METHOD | Teco Diagnostics | 1998-06-29 | Traditional | PDF ↗ |
| K981843 | AST | Abbott Laboratories | 1998-06-29 | Traditional | PDF ↗ |
| K981221 | ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED) | Abbott Laboratories | 1998-04-23 | Traditional | PDF ↗ |
| K981225 | ASPARTATE AMINOTRANSFERASE (AST) | Abbott Laboratories | 1998-04-23 | Traditional | PDF ↗ |
| K980902 | N-ASSAY L AST/GOT | Crestat Diagnostics, Inc. | 1998-03-26 | Traditional | PDF ↗ |
| K980666 | INFINITY AST REAGENT (PROCEDURE NO. 51) | Sigma Diagnostics, Inc. | 1998-03-20 | Traditional | PDF ↗ |
| K980030 | AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | Trace America, Inc. | 1998-01-30 | Traditional | PDF ↗ |
| K974001 | ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30 | Diagnostic Chemicals , Ltd. | 1997-11-13 | Traditional | PDF ↗ |
| K971344 | AST OR SGOT | Carolina Liquid Chemistries Corp. | 1997-04-21 | Traditional | PDF ↗ |
| K965126 | AST/SGOT | Derma Media Lab., Inc. | 1997-01-17 | Traditional | PDF ↗ |
| K961114 | AST INCORPORATING DST | Trace Scientific , Ltd. | 1996-05-23 | Traditional | PDF ↗ |
| K954992 | ROCHE COBAS INTEGRA REAGENT CASSETTES | Roche Diagnostic Systems, Inc. | 1996-01-25 | Traditional | PDF ↗ |
| K954839 | ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV | Sigma Diagnostics, Inc. | 1996-01-05 | Traditional | PDF ↗ |
| K952743 | ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1995-09-29 | Traditional | PDF ↗ |
| K951751 | HICHEM AST REAGENT KIT | Hichem Diagnostics | 1995-08-02 | Traditional | PDF ↗ |
| K944102 | AST QVET | Prisma Systems | 1994-12-13 | Traditional | PDF ↗ |
| K941132 | LIQUID AST (SGOT)REAGENT SET | Pointe Scientific, Inc., | 1994-05-02 | Traditional | PDF ↗ |
| K934413 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ASPARATE AMIMOTRANSFERASE | Eastman Kodak Company | 1994-04-25 | Traditional | PDF ↗ |
| K935181 | ASPARTATE AMINOTRANSFERASE (AST) TEST | Em Diagnostic Systems, Inc. | 1994-01-27 | Traditional | PDF ↗ |
| K932049 | STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020 | Stanbio Laboratory | 1993-11-16 | Traditional | PDF ↗ |
| K925155 | OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT | Olympus Corp. | 1993-01-26 | Traditional | PDF ↗ |
| K924244 | ROCHE REAGENT FOR AST | Roche Diagnostic Systems, Inc. | 1993-01-04 | Traditional | PDF ↗ |
| K923505 | AST (GOT) - ASPARTATE AMINOTRANSFERASE | Randox Laboratories, Ltd. | 1992-11-16 | Traditional | PDF ↗ |
| K923641 | IL TEST AST, PN 35312 | Instrumentation Laboratory CO | 1992-10-26 | Traditional | PDF ↗ |
| K922857 | SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICO | Em Diagnostic Systems, Inc. | 1992-09-09 | Traditional | PDF ↗ |
| K922885 | OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT | Olympus Corp. | 1992-07-28 | Traditional | PDF ↗ |
| K922108 | KING DIAGNOSTICS AST (GOT) REAGENT | King Diagnostics, Inc. | 1992-07-15 | Traditional | PDF ↗ |
| K920336 | MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD | Heraeus Kulzer, Inc. | 1992-03-04 | Traditional | PDF ↗ |
| K915555 | SYNERMED AST/GOT REAGENT KIT | Synermed, Inc. | 1992-01-27 | Traditional | PDF ↗ |
| K914463 | ABBOTT QUICKSTART SGOT, ITEM NUMBER: 5A42 | Em Diagnostic Systems, Inc. | 1992-01-03 | Traditional | PDF ↗ |
| K914025 | TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P) | Technicon Instruments Corp. | 1991-11-22 | Traditional | PDF ↗ |
| K914068 | ABBOTT QUICKSTART ASPARATE AMINOTRANSFERASE TEST | Em Diagnostic Systems, Inc. | 1991-10-02 | Traditional | PDF ↗ |
| K905771 | COULTER DART AST (GOT) REAGENT | Coulter Electronics, Inc. | 1991-02-26 | Traditional | PDF ↗ |
| K903829 | AST REAGENT | Amresco, Inc. | 1990-09-25 | Traditional | PDF ↗ |
| K903197 | ASPARTATE AMINOTRANSFERASE TEST | Em Diagnostic Systems, Inc. | 1990-08-17 | Traditional | PDF ↗ |
| K901104 | PARAMAX ASPARTATE AMINOTRANSFERASE REAGENT | Baxter Healthcare Corp | 1990-03-23 | Traditional | PDF ↗ |
| K897165 | COULTER AST (GOT) REAGENT | Coulter Electronics, Inc. | 1990-02-23 | Traditional | PDF ↗ |
| K896233 | COBAS READY LIVER PROFILE REAGENT STRIP | Roche Diagnostic Systems, Inc. | 1990-02-16 | Traditional | PDF ↗ |
| K896229 | COBAS READY PROFILE 1 REAGENT STRIP | Roche Diagnostic Systems, Inc. | 1990-02-16 | Traditional | PDF ↗ |
| K896228 | COBAS READY CARDIO PROFILE REAGENT STRIP | Roche Diagnostic Systems, Inc. | 1990-02-16 | Traditional | PDF ↗ |
| K896000 | ASPARTATE AMINOTRANFERASE (AST) | American Monitor Corp. | 1990-01-11 | Traditional | PDF ↗ |
| K894180 | ABBOTT AST-ACTIVATED (LIQUID, LIST#01A54) | Abbott Laboratories | 1989-09-13 | Traditional | PDF ↗ |
| K893692 | EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405 | Diagnostic Systems | 1989-08-21 | Traditional | PDF ↗ |
| K892844 | AST REAGENT (PROCEDURE NUMBER 158) | Sigma Chemical Co. | 1989-06-20 | Traditional | PDF ↗ |
| K891468 | AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT | Trace Scientific , Ltd. | 1989-05-22 | Traditional | PDF ↗ |
| K884724 | ASPARTATE AMINOTRANSFERASE (AST) | Catachem, Inc. | 1989-03-08 | Traditional | PDF ↗ |
| K885156 | CLINISTAT SGOT (AST) REAGENT TEST | Heraeus Kulzer, Inc. | 1989-02-02 | Traditional | PDF ↗ |
| K884377 | ASPARTATE AMINOTRANSFERASE TEST ITEM NO. 65654 | Em Diagnostic Systems, Inc. | 1988-12-14 | Traditional | PDF ↗ |
| K880692 | ASPARTATE AMINOTRANSFERASE ASSAY KIT (IFCC) | Diagnostic Chemicals, Ltd. (Usa) | 1988-05-27 | Traditional | PDF ↗ |
| K880276 | AST (SGOT) REAGENT SET | Tech-Neal Scientific, Inc. | 1988-03-03 | Traditional | PDF ↗ |
| K875071 | ASPARTATE AMINOTRANSFERASE AST/SGOT | Tech-Co, Inc. | 1988-02-18 | Traditional | PDF ↗ |
| K874600 | EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010 | Em Diagnostic Systems, Inc. | 1988-01-21 | Traditional | PDF ↗ |
| K872829 | BIOTROL AST/TGO MONOREACTIF | Biotrol, USA, Inc. | 1987-08-13 | Traditional | PDF ↗ |
| K871780 | ULTRAVIOLET ASPARTATE AMINO-TRANS (UV-AST/UV-GOT) | Biochemical Trade, Inc. | 1987-06-04 | Traditional | PDF ↗ |
| K870077 | ASPARTATE AMINOTRANSFERASE (AST)/(GOT) | Catachem, Inc. | 1987-03-06 | Traditional | PDF ↗ |
| K870246 | REFLOTRON(R) AST (GOT) | Boehringer Mannheim Corp. | 1987-02-18 | Traditional | PDF ↗ |
| K864813 | WAKO (TM) AUTOKIT GOT TEST | Wako Chemicals USA, Inc. | 1987-02-13 | Traditional | PDF ↗ |
| K864357 | AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT | Trace Scientific , Ltd. | 1987-02-06 | Traditional | PDF ↗ |
| K863054 | AST S.C.E. (GOT) | J. D. Assoc. | 1987-01-13 | Traditional | PDF ↗ |
| K864302 | WAKO(TM) GOT II - HA | Wako Chemicals USA, Inc. | 1986-12-16 | Traditional | PDF ↗ |
| K863963 | EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95 | Em Diagnostic Systems, Inc. | 1986-11-28 | Traditional | PDF ↗ |
| K863257 | AST/GOT PROCEDURE | Data Medical Associates, Inc. | 1986-09-26 | Traditional | PDF ↗ |
| K863094 | SYSTEMATE (TM) ALANINE TRANSFERASE (ALT) | Em Diagnostic Systems, Inc. | 1986-08-29 | Traditional | PDF ↗ |
| K862832 | MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT | Diagnostic Chemicals, Ltd. (Usa) | 1986-08-12 | Traditional | PDF ↗ |
| K861656 | AST/GOT PROCEDURE | Data Medical Associates, Inc. | 1986-05-29 | Traditional | PDF ↗ |
| K860465 | VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM | Abbott Laboratories | 1986-05-05 | Traditional | PDF ↗ |
| K861283 | AST REAGENT CARTRIDGE | Hi Chem, Inc. | 1986-04-28 | Traditional | PDF ↗ |
| K860725 | AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT | Trace Scientific , Ltd. | 1986-04-07 | Traditional | PDF ↗ |
| K860667 | ASPARTATE AMINOTRANSFERASE (AST/SGOT) REAGENT SET | Sterling Diagnostics, Inc. | 1986-04-03 | Traditional | PDF ↗ |
| K854982 | VISION SGOT (AST) | Abbott Laboratories | 1986-01-14 | Traditional | PDF ↗ |
| K854503 | AST(OPTIMIZED) REAGENT | Sigma Diagnostics, Inc. | 1985-11-25 | Traditional | PDF ↗ |
| K852783 | SGOT/ALT REAGENT | Advanced Biomedical Methods, Inc. | 1985-07-22 | Traditional | PDF ↗ |
| K851994 | AST ASPARTATE AMINOTRANSFERASE REAGENT | Alpkem Corp. | 1985-06-03 | Traditional | PDF ↗ |
| K851865 | AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE | Amresco, Inc. | 1985-05-20 | Traditional | PDF ↗ |
| K851267 | GEMENI AST-LTS REAGENTS | Electro-Nucleonics Laboratories, Inc. | 1985-04-29 | Traditional | PDF ↗ |
| K843109 | ROCHE REAGENT FOR AST | Roche Diagnostic Systems, Inc. | 1984-11-05 | Traditional | PDF ↗ |
| K843333 | SYSTEMATE GOT 67208 | Em Diagnostic Systems, Inc. | 1984-09-20 | Traditional | PDF ↗ |
| K842411 | SIGMA 58-UV ASPARTATE AMINOTRANSFERAS | Sigma Chemical Co. | 1984-08-12 | Traditional | PDF ↗ |
| K842521 | AST/GOT REAGENT SET UV RATE | Sterling Biochemical, Inc. | 1984-08-12 | Traditional | PDF ↗ |
| K842245 | ASPARTATE AMINOTRANSFERASE ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1984-07-18 | Traditional | PDF ↗ |
| K841066 | SGOT-UV REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | Traditional | PDF ↗ |
| K840706 | ASPARTATE AMINOTRANSFERASE REAGENT | American Dade | 1984-04-04 | Traditional | PDF ↗ |
| K830958 | FLOW-PAC SGOT REAGENT | Amresco, Inc. | 1983-05-04 | Traditional | PDF ↗ |
Product code CIT · Class II · Clinical Chemistry. Data: openFDA.