Modifica-Of Emit AED Primidone Assay
FDA 510(k) K832798 · Syva Co.
510(k) numberK832798
Submission
- Device name
- Modifica-Of Emit AED Primidone Assay
- Applicant
- Syva Co.
Mchenry, IL, US - Received
- August 18, 1983
- Decision date
- October 14, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DJD – Enzyme Immunoassay, Primidone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3680
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DJD
| 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 |
| 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 |
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Questions and answers
When was Modifica-Of Emit AED Primidone Assay cleared by the FDA?
Modifica-Of Emit AED Primidone Assay (K832798) received a 510(k) decision of Substantially Equivalent on October 14, 1983, 57 days after the submission was received.
What is the product code of K832798?
The FDA product code is DJD – Enzyme Immunoassay, Primidone, a Class II (moderate risk) device regulated under 21 CFR 862.3680.