FDA product code JZP: Plates, Ouchterlony Agar
JZP is the FDA product code for plates, ouchterlony agar. It is a Class I device, regulated under 21 CFR 866.4600 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under JZP. The average 510(k) review took 14 days (median 14).
Classification
| Field | Value |
|---|---|
| Device name | Plates, Ouchterlony Agar |
| Device class | Class I |
| Regulation | 21 CFR 866.4600 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JZP clearance
Top JZP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Behring Diagnostics, Inc. | 1 | 1976-12-30 |
Most recent JZP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K761270 | Behring Diagnostics, Inc. | IMMUNO-TEC II OT AGAROSE PLATE KIT | 1976-12-30 | 14 |
Recalls for JZP devices
openFDA lists no recalls for product code JZP.
Frequently asked questions
What is FDA product code JZP?
JZP is the FDA product code for plates, ouchterlony agar. It is a Class I device, regulated under 21 CFR 866.4600 and reviewed by the Immunology panel.
What device class is JZP?
Class I, regulation 21 CFR 866.4600. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JZP?
Across 1 cleared submissions the average was 14 days from receipt to decision (median 14).
Which companies have the most JZP clearances?
Behring Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JZP
- Run a recall and safety report across every JZP manufacturer
- Watch product code JZP 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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