LFT
8 FDA 510(k) clearances · Product code
37 daysmedian time to decision
76 days90th percentile
8clearances measured
FDA profile
- Official device name
- Fluorescent Immunoassay, Primidone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3680
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PRIMIDONE FPIA REAGENT SET AND CALIBRATORS (K950028) | Sigma Diagnostics, Inc. | 1995-03-21 |
| STRATUS PRIMIDONE FLUOROMETRIC ENZYME (K904683) | Baxter Healthcare Corp | 1990-11-28 |
| PRIMIDONE (FPIA) KIT (K895567) | Tudor Laboratories, Inc. | 1989-10-20 |
| COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS (K852318) | Roche Diagnostic Systems, Inc. | 1985-06-25 |
| STRATUS PRIMIDONE FLOROMETRIC ENZY (K842196) | American Dade | 1984-07-11 |
| ADVANCE EMIT-AED PRIMEDONE ASSAY (K823741) | Syva Co. | 1983-01-07 |
| PRIMIDONE FLUORESCENT IMMUNOASSAY (K822229) | American Diagnostic Corp. | 1982-08-12 |
| AMES TDA TM PRIMIDONE TEST (K811007) | Miles Laboratories, Inc. | 1981-04-29 |
Track LFT automatically
Every clearance here is in the API, with alerts when new ones post.