Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
DMT · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
39 daysmedian FDA review time
202 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K000410 | SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS | Beckman Coulter, Inc. | 2000-04-10 | 62 | 0 |
| K971506 | SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALC | Beckman Instruments, Inc. | 1997-06-03 | 39 | 0 |
| K934273 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC) | Eastman Kodak Company | 1994-03-21 | 202 | 1 |
| K923783 | ETHYL ALCOHOL ASSAY | Diagnostic Reagents, Inc. | 1993-01-21 | 177 | 0 |
| K864894 | EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93 | Em Diagnostic Systems, Inc. | 1987-01-09 | 25 | 0 |
| K843378 | ETHYL ALCOHOL ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1984-09-14 | 17 | 0 |
| K810467 | EMIT-ST SERUM ETHYL ALCOHOL ASSAY | Syva Co. | 1981-03-06 | 11 | 0 |
| K802621 | EMIT-STM ETHYL ALCOHOL ASSAY | Syva Co. | 1980-10-31 | 11 | 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