GOX — Antigen, B. Pertussis Class I
FDA product code GOX covers "Antigen, B. Pertussis", a Class I medical device regulated under 21 CFR 866.3065. 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
- GOX
- Device Class
- Class I
- Regulation Number
- 866.3065
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K791454 | volu sol medical industries | AGGLUTINOTEST-PERTUSSIS | September 24, 1979 |