GNJ — Antigens, Ha, Echovirus 1-34 Class I
FDA product code GNJ covers "Antigens, Ha, Echovirus 1-34", a Class I medical device regulated under 21 CFR 866.3205. 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
- GNJ
- Device Class
- Class I
- Regulation Number
- 866.3205
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K830173 | jedmed instrument | BERA SH 221 BRIAN STEM AUDIOMETER | May 25, 1983 |