GSH — Antisera, All Types, Listeria Monocytogenes Class I
FDA product code GSH covers "Antisera, All Types, Listeria Monocytogenes", a Class I medical device regulated under 21 CFR 866.3355. 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
- GSH
- Device Class
- Class I
- Regulation Number
- 866.3355
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K791459 | volu sol medical industries | AGGLUTINOTEST-LISTERIA | September 24, 1979 |