Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LDP — Predicate Candidate Screening
37 FDA 510(k) clearances under this product code; the 50 most recent screened below.
57 daysmedian FDA review time
282 days90th percentile
37clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261364 | Atellica CH Acetaminophen 2 (ACTM) | Siemens Healthcare Diagnostics, Inc. | 2026-07-24 | 88 | 0 |
| K202644 | Acetaminophen | Sekisui Diagnostics P.E.I., Inc. | 2022-02-18 | 525 | 0 |
| K180835 | SEKURE Acetaminophen L3K Assay | Sekisui Diagnostics P.E.I., Inc. | 2019-02-08 | 315 | 0 |
| K110726 | ROCHE ACETAMINOPHEN ASSAY | Roche Diagnostics | 2011-12-23 | 282 | 0 |
| K100200 | ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 | Siemens Healthcare Diagnostics | 2010-08-02 | 189 | 1 |
| K081938 | ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS | Genzyme Diagnostics P.E.I., Inc. | 2009-05-01 | 297 | 0 |
| K061655 | DIMENSION VISTA FLEX REAGENT CARTRIDGES | Dade Behring, Inc. | 2006-07-10 | 27 | 3 |
| K043242 | TRIAGE TOX DRUG SCREEN | Biosite Incorporated | 2005-02-28 | 97 | 1 |
| K042330 | ACETAMINOPHEN-SL ASSAY | Diagnostic Chemicals , Ltd. | 2005-01-07 | 133 | 2 |
| K020792 | ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | 2002-07-11 | 122 | 0 |
| K013757 | ROCHE ACETAMINOPHEN | Roche Diagnostics Corp. | 2002-01-08 | 56 | 1 |
| K011465 | SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX | Beckman Coulter, Inc. | 2001-06-08 | 25 | 1 |
| K002974 | EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAM | Dade Behring, Inc. | 2000-10-11 | 55 | 0 |
| K000494 | SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT | Beckman Coulter, Inc. | 2000-04-14 | 59 | 1 |
| K991598 | COBAS INTEGRA ACETAMINOPHEN | Roche Diagnostics Corp. | 1999-07-22 | 73 | 1 |
| K981059 | ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30. | Diagnostic Chemicals , Ltd. | 1998-05-12 | 50 | 0 |
| K980031 | ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10 | Diagnostic Chemicals , Ltd. | 1998-03-03 | 57 | 0 |
| K963244 | ACETAMINOPHEN FLEX REAGENT CARTRIDGE | Dade Intl., Inc. | 1996-09-23 | 35 | 0 |
| K961373 | ACETAMINOPHEN SERUM TOX EIA ASSAY | Diagnostic Reagents, Inc. | 1996-07-08 | 90 | 0 |
| K954933 | EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-12-18 | 52 | 1 |
| K952949 | ACETAMINOPHEN ASSAY | Diagnostic Chemicals , Ltd. | 1995-09-06 | 72 | 0 |
| K953094 | AXSYM ACETAMINOPHEN | Abbott Laboratories | 1995-08-24 | 52 | 0 |
| K931257 | ACETASITE | Gds Diagnostics | 1993-07-08 | 118 | 0 |
| K897118 | SATELLITE A BLOOD ACETAMINOPHEN MONITORING SYSTEM | Medisense, Inc. | 1990-05-10 | 135 | 0 |
| K885097 | ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13 | Diagnostic Chemicals, Ltd. (Usa) | 1989-01-11 | 33 | 0 |
| K882719 | EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653 | Em Diagnostic Systems, Inc. | 1988-08-08 | 38 | 0 |
| K880829 | GDS ENZYMATIC ACETAMINOPHEN REAGENT | Gds Technology, LLC | 1988-05-27 | 87 | 0 |
| K851278 | ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870 | Stanbio Laboratory | 1985-04-17 | 16 | 0 |
| K844962 | EMIT QST ACETAMINOPHEN ASSAY | Syva Co. | 1985-01-18 | 25 | 0 |
| K842548 | ACA ACETAMINOPHEN ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1984-08-16 | 45 | 0 |
| K840941 | TDX ACETAMINOPHEN | Abbott Laboratories | 1984-05-11 | 67 | 0 |
| K832045 | ACETAMINOPHER ASSAY KIT | Quantimetrix Corp. | 1983-10-04 | 102 | 0 |
| K832567 | ACETAMINOPHEN(PARACETAMOL | Bio-Analytics Laboratories, Inc. | 1983-09-12 | 41 | 0 |
| K822313 | PROCEDURE #430 & REAGENTS FOR ACETAMIN | Sigma Chemical Co. | 1982-08-24 | 21 | 0 |
| K821969 | ACETAMINOPHEN STAT-PAK REAGENT SET | Clin Tech Diagnostics Corp. | 1982-07-16 | 15 | 0 |
| K821379 | EMIT-TOX ACETAMINOPHEN ASSAY | Syva Co. | 1982-05-28 | 18 | 0 |
| K801014 | STANBIO ACETAMINOPHEN TEST SET #0850 | Stanbio Laboratory | 1980-06-20 | 53 | 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