Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CJE — Predicate Candidate Screening
124 FDA 510(k) clearances under this product code; the 50 most recent screened below.
44 daysmedian FDA review time
131 days90th percentile
124clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251074 | Tru Liver Health Test Panel | Truvian Health | 2025-12-19 | 255 | 0 |
| K240468 | Alkaline Phosphatase | Abbott Laboratories Diagnostics Division | 2024-10-16 | 239 | 0 |
| K223317 | Alkaline Phosphatase2 | Abbott Ireland Diagnostics Division | 2023-07-21 | 266 | 0 |
| K191245 | Yumizen C1200 ALP, Yumizen C1200 Albumin | HORIBA ABX SAS | 2019-08-30 | 113 | 0 |
| K171971 | Comprehensive Metabolic Panel, skyla Clinical Chemistry Anal | Lite-On Technology Corp. H.S.P.B. | 2018-01-25 | 209 | 0 |
| K171080 | ALP IFCC Gen.2 | Roche Diagnostics Operations (Rdo) | 2017-05-10 | 29 | 0 |
| K162275 | Randox RX Daytona Plus Alkaline Phosphatase (ALP) | Randox Laboratories Limited | 2017-04-21 | 252 | 0 |
| K131351 | ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGE | Alfa Wassermann Diagnostic Technologies, LLC | 2013-08-15 | 97 | 1 |
| K130141 | S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) | Hitachi Chemical Diagnostics, Inc. | 2013-03-22 | 59 | 0 |
| K113436 | ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE L | Alfa Wassermann | 2012-07-12 | 234 | 0 |
| K113269 | ELITTECH CLINICAL SYSTEMS ALP IFCC SL | Elitechgroup | 2011-12-29 | 55 | 0 |
| K101090 | EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND | Medica Corp. | 2011-05-20 | 396 | 0 |
| K073191 | ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL | Thermofisher Scientific OY | 2008-02-28 | 107 | 0 |
| K060205 | GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANA | Horiba Abx | 2006-07-21 | 176 | 1 |
| K033185 | COBAS INTEGRA ALP IFCC GEN.2 | Roche Diagnostics Corp. | 2003-10-14 | 13 | 0 |
| K023807 | MODIFICATION TO ALKP | Abbott Laboratories | 2002-12-26 | 42 | 0 |
| K013983 | WIENER LAB. ALP 405 | Wiener Laboratories Saic | 2002-01-28 | 56 | 0 |
| K012518 | TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODE | Thermo Dma, Inc. | 2001-10-09 | 64 | 0 |
| K011599 | ALKALINE PHOSPHATASE LIQUID REAGENT | Jas Diagnostics, Inc. | 2001-07-20 | 57 | 0 |
| K003093 | ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30 | Diagnostic Chemicals , Ltd. | 2000-11-27 | 55 | 0 |
| K002285 | ATAC PAK ALP REAGENT KIT | Elan Diagnostics | 2000-09-26 | 62 | 0 |
| K000067 | ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 | Teco Diagnostics | 2000-01-20 | 10 | 0 |
| K991762 | ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 | A.P. Total Care, Inc. | 1999-09-02 | 101 | 0 |
| K991387 | ELAN ALKALINE PHOSPHATE REAGENT KIT | Elan Holdings, Inc. | 1999-05-19 | 28 | 0 |
| K990024 | CARESIDE ALKALINE PHOSPHATASE | Careside, Inc. | 1999-01-13 | 8 | 0 |
| K981897 | ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT | Roche Diagnostic Systems, Inc. | 1998-08-26 | 86 | 0 |
| K981806 | ALKP | Abbott Laboratories | 1998-06-22 | 32 | 1 |
| K981245 | ALKALINE PHOSPHATASE (ALKP) | Abbott Laboratories | 1998-05-20 | 44 | 0 |
| K980316 | ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-3 | Diagnostic Chemicals , Ltd. | 1998-02-12 | 16 | 0 |
| K973588 | LIQUID ALKALINE PHOSHATASE REAGENT SET | Pointe Scientific, Inc., | 1997-10-22 | 30 | 18 |
| K971463 | ALP REAGENT SET | Carolina Liquid Chemistries Corp. | 1997-05-16 | 25 | 0 |
| K964914 | ALKALINE PHOSPHATASE | Derma Media Lab., Inc. | 1997-02-04 | 57 | 0 |
| K954840 | ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245 | Sigma Diagnostics, Inc. | 1996-02-28 | 131 | 0 |
| K952746 | ALKALINE PHOSPHATASE REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1995-11-27 | 164 | 0 |
| K951584 | ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247 | Sigma Diagnostics, Inc. | 1995-08-11 | 127 | 0 |
| K942997 | ALKALINE PHOSPHATASE (ALKP) QVET | Prisma Systems | 1994-12-29 | 189 | 0 |
| K941313 | STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET | Stanbio Laboratory | 1994-05-17 | 60 | 0 |
| K935182 | EMDS ALKANINE PHOSPHATASE (ALP) TEST | Em Diagnostic Systems, Inc. | 1993-12-09 | 43 | 0 |
| K931986 | AMP ALKALINE PHOSPHATASE REAGENT KIT | Synermed, Inc. | 1993-09-08 | 139 | 0 |
| K923507 | ALKALINE PHOSPHATASE KIT | Randox Laboratories, Ltd. | 1992-12-03 | 141 | 0 |
| K925156 | OLYMPUS ALKALINE PHOSPHATASE REAGENT | Olympus Corp. | 1992-11-18 | 36 | 0 |
| K924574 | EMDS ALKALINE PHOSPHATASE (ALP) TEST | Em Diagnostic Systems, Inc. | 1992-11-09 | 60 | 0 |
| K923527 | OLYMPUS ALKALINE PHOSPHATASE REAGENT | Olympus Corp. | 1992-09-28 | 74 | 0 |
| K913921 | ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38 | Em Diagnostic Systems, Inc. | 1991-11-22 | 80 | 0 |
| K910639 | SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483 | Em Diagnostic Systems, Inc. | 1991-04-12 | 58 | 0 |
| K905650 | KINETIC ALKALINE PHOSPHATASE DETERMINATION | Biochemical Trade, Inc. | 1991-02-13 | 57 | 0 |
| K905684 | ALKALINE PHOSPHATASE | Amresco, Inc. | 1990-12-28 | 9 | 0 |
| K904030 | SYNERMED ALKALINE PHOSPHATASE REAGENT KIT | Synermed, Inc. | 1990-09-27 | 27 | 0 |
| K902560 | ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT | Roche Diagnostic Systems, Inc. | 1990-07-17 | 36 | 0 |
| K900250 | AMRESCO ALKALINE PHOSPHATASE REAGENTS 7780 & 7781 | American Research Products Co. | 1990-03-01 | 43 | 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