GNO — Antisera, Cf, Coxsackievirus A 1-24, B 1-6 Class I
FDA product code GNO covers "Antisera, Cf, Coxsackievirus A 1-24, B 1-6", a Class I medical device regulated under 21 CFR 866.3145. 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
- GNO
- Device Class
- Class I
- Regulation Number
- 866.3145
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K853279 | hillcrest biologicals | COXSACKIE A2 CF ANTIGEN, A4, A10 & A16 | November 7, 1985 |