GNN — Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6 Class I
FDA product code GNN covers "Antisera, Neutralization, 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
- GNN
- 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 |
|---|---|---|---|
| K823111 | kelleher | NYSTYMOGRAPH ACCESS | November 22, 1982 |