DJD
8 FDA 510(k) clearances · Product code
50 daysmedian time to decision
57 days90th percentile
8clearances measured
FDA profile
- Official device name
- Enzyme 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 |
|---|---|---|
| ACE PRIMIDONE REAGENT, AED CALIBRATORS (K973582) | Schiapparelli Biosystems, Inc. | 1997-11-12 |
| EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE (K910527) | Syva Co. | 1991-03-14 |
| EMIT QST PRIMIDONE ASSAY (K840939) | Syva Co. | 1984-04-24 |
| MODIFICA-OF EMIT AED PRIMIDONE ASSAY (K832798) | Syva Co. | 1983-10-14 |
| PRIMIDONE REAGENT TEST KIT (K820138) | Beckman Instruments, Inc. | 1982-01-28 |
| TDX PRIMIDONE (K813597) | Abbott Laboratories | 1982-01-22 |
| AMES TDA PRIMIDONE TEST (K802654) | Miles Laboratories, Inc. | 1980-11-12 |
| ANALYTICAL TEST PACK, PRIMIDONE (K781957) | E.I. Dupont DE Nemours & Co., Inc. | 1979-01-10 |
Track DJD automatically
Every clearance here is in the API, with alerts when new ones post.