Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CKA — Predicate Candidate Screening
127 FDA 510(k) clearances under this product code; the 50 most recent screened below.
41 daysmedian FDA review time
102 days90th percentile
127clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120945 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITA | Hitachi Chemical Diagnostics, Inc. | 2013-06-07 | 435 | 0 |
| K113382 | ACE ALT REAGENT | Alfa Wassermann | 2012-07-19 | 246 | 1 |
| K061020 | DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMI | Dade Behring, Inc. | 2006-05-10 | 27 | 0 |
| K020487 | CARESIDE ALT | Careside, Inc. | 2002-06-04 | 111 | 0 |
| K980028 | ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABI | Trace America, Inc. | 1998-02-02 | 28 | 0 |
| K973869 | TRACE REAGENT LINE FOR THE COBAS MIRA | Trace America, Inc. | 1998-01-07 | 105 | 0 |
| K974003 | ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 3 | Diagnostic Chemicals , Ltd. | 1997-12-05 | 45 | 0 |
| K971323 | ALT OR SGPT | Carolina Liquid Chemistries Corp. | 1997-04-21 | 11 | 0 |
| K965134 | ALT/SGPT | Derma Media Lab., Inc. | 1997-02-18 | 57 | 0 |
| K961123 | ALT INCORPORATING DST | Trace Scientific , Ltd. | 1996-04-25 | 35 | 0 |
| K952427 | CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPH | Beckman Instruments, Inc. | 1995-09-21 | 120 | 0 |
| K952744 | ALANINE AMINOTRANSFERASE REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1995-08-07 | 52 | 0 |
| K951332 | PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT | Dade Intl., Inc. | 1995-06-19 | 102 | 0 |
| K951818 | HICHEM ALT REAGENT KIT | Hi Chem, Inc. | 1995-05-15 | 25 | 0 |
| K944080 | ALT QVET | Prisma Systems | 1994-11-22 | 92 | 0 |
| K941314 | STANBIO ALT/GPT (LUQUI-UV) TEST SET | Stanbio Laboratory | 1994-07-20 | 124 | 0 |
| K941497 | SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY | Solarcare, Inc. | 1994-05-24 | 57 | 0 |
| K941287 | LIQUID ALT(SGPT) REAGENT SET | Pointe Scientific, Inc., | 1994-05-03 | 47 | 8 |
| K935180 | ALANINE AMINOTRANSFERASE (ALT) TEST | Em Diagnostic Systems, Inc. | 1994-01-13 | 79 | 0 |
| K930070 | HEMOCARD HEMOGLOBIN E | Isolab, Inc. | 1993-04-08 | 92 | 0 |
| K925339 | OLYLMPUS ALANINE AMINOTRANSFERASE REAGENT | Olympus Corp. | 1993-02-05 | 108 | 0 |
| K923510 | ALT (GPT) - ALANINE AMINOTRANSFERASE | Randox Laboratories, Ltd. | 1992-11-16 | 124 | 0 |
| K924245 | ROCHE REAGENT FOR ALT | Roche Diagnostic Systems, Inc. | 1992-10-22 | 59 | 0 |
| K923257 | EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000 | Em Diagnostic Systems, Inc. | 1992-09-28 | 88 | 0 |
| K923623 | IL TEST ALT, PN 35311 | Instrumentation Laboratory CO | 1992-09-17 | 58 | 0 |
| K922884 | OLYMPUS ALANINE AMINOTRANSFERASE REAGENT | Olympus Corp. | 1992-07-28 | 42 | 0 |
| K922109 | KING DIAGNOSTICS ALT (GPT) REAGENT | King Diagnostics, Inc. | 1992-06-04 | 30 | 0 |
| K921016 | SYNERMED ALT/GPT REAGENT KIT | Synermed, Inc. | 1992-05-07 | 65 | 0 |
| K920335 | MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD | Heraeus Kulzer, Inc. | 1992-03-24 | 60 | 0 |
| K914464 | ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43 | Em Diagnostic Systems, Inc. | 1991-11-22 | 46 | 0 |
| K913846 | ABBOTT QUICKSTART ALANINE AMINOTRANSFER | Em Diagnostic Systems, Inc. | 1991-09-19 | 22 | 0 |
| K905767 | COULTER DART ALT (GPT) REAGENT | Coulter Electronics, Inc. | 1991-01-25 | 29 | 0 |
| K903198 | ALANINE AMINOTRANSFERASE TEST | Em Diagnostic Systems, Inc. | 1990-09-12 | 55 | 0 |
| K901702 | NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522 | American Research Products Co. | 1990-04-25 | 13 | 0 |
| K900905 | TECHNICON AXON SYSTEM REAGENT METHODS | Technicon Instruments Corp. | 1990-04-03 | 35 | 0 |
| K901105 | PARAMAX ALANINE AMINOTRANSFERASE REAGENT | Baxter Healthcare Corp | 1990-03-23 | 15 | 0 |
| K897163 | COULTER ALT (GPT) REAGENT | Coulter Electronics, Inc. | 1990-03-09 | 71 | 0 |
| K896234 | COBAS READY STAT PROFILE REAGENT STRIP | Roche Diagnostic Systems, Inc. | 1990-02-16 | 108 | 0 |
| K896001 | ALANINE AMINOTRANSFERASE (ALT) | American Monitor Corp. | 1989-11-13 | 31 | 0 |
| K892930 | TECHNICON DAX TM SYSTEM ADDITIONAL ANALYTES | Technicon Instruments Corp. | 1989-07-27 | 97 | 0 |
| K893752 | ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403 | Em Diagnostic Systems, Inc. | 1989-07-20 | 62 | 0 |
| K893560 | ALT REAGENT (PROCEDURE NUMBER 159) | Sigma Chemical Co. | 1989-07-20 | 72 | 0 |
| K890698 | ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55) | Abbott Laboratories | 1989-04-10 | 59 | 0 |
| K891469 | ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT | Trace Scientific , Ltd. | 1989-04-04 | 20 | 0 |
| K885144 | CLINISTAT SGPT (ALT) SERUM GLUTAMATE PYRUVATE TRAN | Heraeus Kulzer, Inc. | 1989-02-02 | 49 | 0 |
| K884376 | ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652 | Em Diagnostic Systems, Inc. | 1989-01-11 | 85 | 0 |
| K884936 | ALANINE AMINOTRANSFERASE | Catachem, Inc. | 1989-01-03 | 39 | 0 |
| K883181 | SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE | Beckman Instruments, Inc. | 1988-09-19 | 54 | 2 |
| K883205 | ALTLTS ALANINE AMINO TRANSFERASE ALT | Electro-Nucleonics, Inc. | 1988-09-09 | 43 | 0 |
| K875079 | MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE | Miles Laboratories, Inc. | 1988-04-05 | 118 | 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