FDA product code DJD: Enzyme Immunoassay, Primidone
DJD is the FDA product code for enzyme immunoassay, primidone. It is a Class II device, regulated under 21 CFR 862.3680 and reviewed by the Clinical Toxicology panel. FDA has cleared 8 510(k) submissions under DJD, from 6 different applicants. The average 510(k) review took 37 days (median 42).
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Primidone |
| Device class | Class II |
| Regulation | 21 CFR 862.3680 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DJD clearance
Top DJD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 3 | 1991-03-14 |
| Schiapparelli Biosystems, Inc. | 1 | 1997-11-12 |
| Beckman Instruments, Inc. | 1 | 1982-01-28 |
| Abbott Laboratories | 1 | 1982-01-22 |
| Miles Laboratories, Inc. | 1 | 1980-11-12 |
1 more applicants have DJD clearances. See the full list in Caduvo.
Most recent DJD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K973582 | Schiapparelli Biosystems, Inc. | ACE PRIMIDONE REAGENT, AED CALIBRATORS | 1997-11-12 | 51 |
| K910527 | Syva Co. | EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE | 1991-03-14 | 35 |
| K840939 | Syva Co. | EMIT QST PRIMIDONE ASSAY | 1984-04-24 | 50 |
| K832798 | Syva Co. | MODIFICA-OF EMIT AED PRIMIDONE ASSAY | 1983-10-14 | 57 |
| K820138 | Beckman Instruments, Inc. | PRIMIDONE REAGENT TEST KIT | 1982-01-28 | 10 |
Recalls for DJD devices
openFDA lists no recalls for product code DJD.
Frequently asked questions
What is FDA product code DJD?
DJD is the FDA product code for enzyme immunoassay, primidone. It is a Class II device, regulated under 21 CFR 862.3680 and reviewed by the Clinical Toxicology panel.
What device class is DJD?
Class II, regulation 21 CFR 862.3680. Typical premarket route: 510(k).
How long does a 510(k) take for product code DJD?
Across 8 cleared submissions the average was 37 days from receipt to decision (median 42).
Which companies have the most DJD clearances?
Syva Co. (3); Schiapparelli Biosystems, Inc. (1); Beckman Instruments, Inc. (1); Abbott Laboratories (1); Miles Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DJD
- Run a recall and safety report across every DJD manufacturer
- Watch product code DJD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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