FDA product code MDJ: Reagents, Cysticercosis
MDJ is the FDA product code for reagents, cysticercosis. It is a Class I device, regulated under 21 CFR 866.3200 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under MDJ. The average 510(k) review took 226 days (median 226).
Classification
| Field | Value |
|---|---|
| Device name | Reagents, Cysticercosis |
| Device class | Class I |
| Regulation | 21 CFR 866.3200 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MDJ clearance
Top MDJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lmd Laboratories | 1 | 1990-10-04 |
Most recent MDJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K900780 | Lmd Laboratories | CYSTICERCOSIS SEROLOGICAL REAGENTS | 1990-10-04 | 226 |
Recalls for MDJ devices
openFDA lists no recalls for product code MDJ.
Frequently asked questions
What is FDA product code MDJ?
MDJ is the FDA product code for reagents, cysticercosis. It is a Class I device, regulated under 21 CFR 866.3200 and reviewed by the Microbiology panel.
What device class is MDJ?
Class I, regulation 21 CFR 866.3200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MDJ?
Across 1 cleared submissions the average was 226 days from receipt to decision (median 226).
Which companies have the most MDJ clearances?
Lmd Laboratories (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MDJ
- Run a recall and safety report across every MDJ manufacturer
- Watch product code MDJ 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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