GPS — Antigen, Cf, Q Fever Class I
FDA product code GPS covers "Antigen, Cf, Q Fever", a Class I medical device regulated under 21 CFR 866.3500. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- GPS
- Device Class
- Class I
- Regulation Number
- 866.3500
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K843672 | institute virion | Q-FEVER | August 8, 1985 |