Enzyme Immunoassay, Primidone
FDA product code DJD · Class II (moderate risk) · 21 CFR 862.3680 · Clinical Toxicology
8510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973582 | Ace Primidone Reagent, AED CalibratorsDJD · Traditional | Schiapparelli Biosystems, Inc. | 11/12/1997SE |
| K910527 | Emit Convenience Pack for the Cobas Mira PrimidoneDJD · Traditional | Syva Co. | 03/14/1991SE |
| K840939 | Emit QST Primidone AssayDJD · Traditional | Syva Co. | 04/24/1984SE |
| K832798 | Modifica-Of Emit AED Primidone AssayDJD · Traditional | Syva Co. | 10/14/1983SE |
| K820138 | Primidone Reagent Test KitDJD · Traditional | Beckman Instruments, Inc. | 01/28/1982SE |
| K813597 | TDX PrimidoneDJD · Traditional | Abbott Laboratories | 01/22/1982SE |
| K802654 | Ames Tda Primidone TestDJD · Traditional | Miles Laboratories, Inc. | 11/12/1980SE |
| K781957 | Analytical Test Pack, PrimidoneDJD · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 01/10/1979SE |