Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
LFT · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
37 daysmedian FDA review time
76 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K950028 | PRIMIDONE FPIA REAGENT SET AND CALIBRATORS | Sigma Diagnostics, Inc. | 1995-03-21 | 76 | 0 |
| K904683 | STRATUS PRIMIDONE FLUOROMETRIC ENZYME | Baxter Healthcare Corp | 1990-11-28 | 44 | 0 |
| K895567 | PRIMIDONE (FPIA) KIT | Tudor Laboratories, Inc. | 1989-10-20 | 44 | 0 |
| K852318 | COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS | Roche Diagnostic Systems, Inc. | 1985-06-25 | 25 | 0 |
| K842196 | STRATUS PRIMIDONE FLOROMETRIC ENZY | American Dade | 1984-07-11 | 37 | 0 |
| K823741 | ADVANCE EMIT-AED PRIMEDONE ASSAY | Syva Co. | 1983-01-07 | 25 | 0 |
| K822229 | PRIMIDONE FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | 1982-08-12 | 16 | 0 |
| K811007 | AMES TDA TM PRIMIDONE TEST | Miles Laboratories, Inc. | 1981-04-29 | 15 | 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