Enzyme Immunoassay, Primidone
The Enzyme Immunoassay for Primidone is a laboratory test using enzyme immunoassay technology to quantify primidone, an antiepileptic drug, in patient serum or plasma for therapeutic drug monitoring. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3680 within the Clinical Toxicology specialty. The device is eligible for third-party 510(k) review.
Research product code DJD in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- DJD
- Device Class
- FDA class 2
- Regulation Number
- 862.3680
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K973582 | ACE PRIMIDONE REAGENT, AED CALIBRATORS | Nov 12, 1997 | Substantially Equivalent | Schiapparelli Biosystems, Inc. |
| K910527 | EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE | Mar 14, 1991 | Substantially Equivalent | Syva Co. |
| K840939 | EMIT QST PRIMIDONE ASSAY | Apr 24, 1984 | Substantially Equivalent | Syva Co. |
| K832798 | MODIFICA-OF EMIT AED PRIMIDONE ASSAY | Oct 14, 1983 | Substantially Equivalent | Syva Co. |
| K820138 | PRIMIDONE REAGENT TEST KIT | Jan 28, 1982 | Substantially Equivalent | Beckman Instruments, Inc. |
| K813597 | TDX PRIMIDONE | Jan 22, 1982 | Substantially Equivalent | Abbott Laboratories |
| K802654 | AMES TDA PRIMIDONE TEST | Nov 12, 1980 | Substantially Equivalent | Miles Laboratories, Inc. |
| K781957 | ANALYTICAL TEST PACK, PRIMIDONE | Jan 10, 1979 | Substantially Equivalent | E.I. Dupont DE Nemours & Co., Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.