Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CIT — Predicate Candidate Screening
139 FDA 510(k) clearances under this product code; the 50 most recent screened below.
46 daysmedian FDA review time
117 days90th percentile
139clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093883 | AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL | Seppim S.A.S. | 2010-09-20 | 276 | 0 |
| K080485 | ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GO | Diasys Diagnostics Systems GmbH | 2008-12-04 | 286 | 0 |
| K071525 | ACTIVATED ASPARTATE AMINOTRANSFERASE | Abbott Laboratories | 2008-03-19 | 289 | 1 |
| K071580 | AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTRO | Thermofisher Scientific OY | 2007-10-03 | 117 | 0 |
| K071211 | COBAS C 111 ANALYZER | Roche Diagnostics | 2007-07-30 | 90 | 3 |
| K060318 | HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZE | Horiba Abx | 2006-08-08 | 181 | 1 |
| K023551 | WIENER LAB GOT (AST) UV AA LIQUIDA | Wiener Laboratories Saic | 2002-12-09 | 48 | 0 |
| K013698 | AST (SGOT) | Jas Diagnostics, Inc. | 2001-12-21 | 44 | 0 |
| K013145 | WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITES | Wiener Laboratories Saic | 2001-11-27 | 68 | 0 |
| K010488 | ATAC PAK AST REAGENT KIT | Elan Holdings, Inc. | 2001-04-09 | 48 | 0 |
| K001679 | VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS C | Ortho-Clinical Diagnostics, Inc. | 2000-06-28 | 27 | 2 |
| K993468 | WAKO L-TYPE GOT TEST | Wako Chemicals USA, Inc. | 1999-12-16 | 64 | 0 |
| K992136 | BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) | Bayer Corp. | 1999-11-09 | 138 | 0 |
| K992801 | SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGM | Sigma Diagnostics, Inc. | 1999-09-28 | 40 | 0 |
| K991663 | AST/SGOT | A.P. Total Care, Inc. | 1999-06-30 | 47 | 0 |
| K990009 | CARESIDE AST | Careside, Inc. | 1999-03-16 | 71 | 0 |
| K983131 | AST | Abbott Laboratories | 1998-09-28 | 20 | 0 |
| K981650 | AST/SGOT LIQUID REAGENT - KINETIC METHOD | Teco Diagnostics | 1998-06-29 | 49 | 0 |
| K981843 | AST | Abbott Laboratories | 1998-06-29 | 34 | 0 |
| K981225 | ASPARTATE AMINOTRANSFERASE (AST) | Abbott Laboratories | 1998-04-23 | 20 | 0 |
| K981221 | ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED) | Abbott Laboratories | 1998-04-23 | 20 | 0 |
| K980902 | N-ASSAY L AST/GOT | Crestat Diagnostics, Inc. | 1998-03-26 | 16 | 0 |
| K980666 | INFINITY AST REAGENT (PROCEDURE NO. 51) | Sigma Diagnostics, Inc. | 1998-03-20 | 28 | 0 |
| K980030 | AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABI | Trace America, Inc. | 1998-01-30 | 25 | 0 |
| K974001 | ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10 | Diagnostic Chemicals , Ltd. | 1997-11-13 | 23 | 0 |
| K971344 | AST OR SGOT | Carolina Liquid Chemistries Corp. | 1997-04-21 | 11 | 0 |
| K965126 | AST/SGOT | Derma Media Lab., Inc. | 1997-01-17 | 25 | 0 |
| K961114 | AST INCORPORATING DST | Trace Scientific , Ltd. | 1996-05-23 | 64 | 0 |
| K954992 | ROCHE COBAS INTEGRA REAGENT CASSETTES | Roche Diagnostic Systems, Inc. | 1996-01-25 | 86 | 0 |
| K954839 | ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV | Sigma Diagnostics, Inc. | 1996-01-05 | 77 | 0 |
| K952743 | ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1995-09-29 | 105 | 0 |
| K951751 | HICHEM AST REAGENT KIT | Hichem Diagnostics | 1995-08-02 | 107 | 0 |
| K944102 | AST QVET | Prisma Systems | 1994-12-13 | 112 | 0 |
| K941132 | LIQUID AST (SGOT)REAGENT SET | Pointe Scientific, Inc., | 1994-05-02 | 54 | 3 |
| K934413 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ASPARATE AMIMOTR | Eastman Kodak Company | 1994-04-25 | 227 | 1 |
| K935181 | ASPARTATE AMINOTRANSFERASE (AST) TEST | Em Diagnostic Systems, Inc. | 1994-01-27 | 93 | 0 |
| K932049 | STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020 | Stanbio Laboratory | 1993-11-16 | 203 | 0 |
| K925155 | OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT | Olympus Corp. | 1993-01-26 | 105 | 0 |
| K924244 | ROCHE REAGENT FOR AST | Roche Diagnostic Systems, Inc. | 1993-01-04 | 133 | 0 |
| K923505 | AST (GOT) - ASPARTATE AMINOTRANSFERASE | Randox Laboratories, Ltd. | 1992-11-16 | 124 | 0 |
| K923641 | IL TEST AST, PN 35312 | Instrumentation Laboratory CO | 1992-10-26 | 97 | 0 |
| K922857 | SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICO | Em Diagnostic Systems, Inc. | 1992-09-09 | 86 | 0 |
| K922885 | OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT | Olympus Corp. | 1992-07-28 | 42 | 0 |
| K922108 | KING DIAGNOSTICS AST (GOT) REAGENT | King Diagnostics, Inc. | 1992-07-15 | 71 | 0 |
| K920336 | MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD | Heraeus Kulzer, Inc. | 1992-03-04 | 40 | 0 |
| K915555 | SYNERMED AST/GOT REAGENT KIT | Synermed, Inc. | 1992-01-27 | 47 | 0 |
| K914463 | ABBOTT QUICKSTART SGOT, ITEM NUMBER: 5A42 | Em Diagnostic Systems, Inc. | 1992-01-03 | 88 | 0 |
| K914025 | TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P) | Technicon Instruments Corp. | 1991-11-22 | 74 | 0 |
| K914068 | ABBOTT QUICKSTART ASPARATE AMINOTRANSFERASE TEST | Em Diagnostic Systems, Inc. | 1991-10-02 | 21 | 0 |
| K905771 | COULTER DART AST (GOT) REAGENT | Coulter Electronics, Inc. | 1991-02-26 | 61 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda