DJD — Enzyme Immunoassay, Primidone Class II
FDA product code DJD covers "Enzyme Immunoassay, Primidone", a Class II medical device regulated under 21 CFR 862.3680. Submissions are reviewed by the Clinical Toxicology panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DJD
- Device Class
- Class II
- Regulation Number
- 862.3680
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K973582 | schiapparelli biosystems | ACE PRIMIDONE REAGENT, AED CALIBRATORS | November 12, 1997 |
| K910527 | syva | EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE | March 14, 1991 |
| K840939 | syva | EMIT QST PRIMIDONE ASSAY | April 24, 1984 |
| K832798 | syva | MODIFICA-OF EMIT AED PRIMIDONE ASSAY | October 14, 1983 |
| K820138 | beckman instruments | PRIMIDONE REAGENT TEST KIT | January 28, 1982 |
| K813597 | abbott laboratories | TDX PRIMIDONE | January 22, 1982 |
| K802654 | miles laboratories | AMES TDA PRIMIDONE TEST | November 12, 1980 |
| K781957 | e.i. dupont de nemours and co | ANALYTICAL TEST PACK, PRIMIDONE | January 10, 1979 |