FDA product code OSK: Anti-Glutamate Receptor (Type Nmda) Ifa
OSK is the FDA product code for anti-glutamate receptor (type nmda) ifa. It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under OSK. The average 510(k) review took 252 days (median 252).
Definition
Intended for the qualitative determination of autoantibodies against glutamate receptor (type NMDA) in human serum. Used as an aid in the diagnosis of anti-glutamate receptor (type NMDA) autoimmune encephalitis in conjunction with other laboratory and clinical findings.
Classification
| Field | Value |
|---|---|
| Device name | Anti-Glutamate Receptor (Type Nmda) Ifa |
| Device class | Class II |
| Regulation | 21 CFR 866.5660 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every OSK clearance
Top OSK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Euroimmun Us, Inc. | 1 | 2010-09-13 |
Most recent OSK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K100017 | Euroimmun Us, Inc. | EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM | 2010-09-13 | 252 |
Recalls for OSK devices
openFDA lists no recalls for product code OSK.
Frequently asked questions
What is FDA product code OSK?
OSK is the FDA product code for anti-glutamate receptor (type nmda) ifa. It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel.
What device class is OSK?
Class II, regulation 21 CFR 866.5660. Typical premarket route: 510(k).
How long does a 510(k) take for product code OSK?
Across 1 cleared submissions the average was 252 days from receipt to decision (median 252).
Which companies have the most OSK clearances?
Euroimmun Us, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OSK
- Run a recall and safety report across every OSK manufacturer
- Watch product code OSK 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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