GSS — Antisera, Fluorescent, Pseudomonas Aeruginosa Class II
FDA product code GSS covers "Antisera, Fluorescent, Pseudomonas Aeruginosa", a Class II medical device regulated under 21 CFR 866.3415. 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
- GSS
- Device Class
- Class II
- Regulation Number
- 866.3415
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K921461 | symbiosis | TURKEL THORACENTESIS NEEDLE | July 30, 1992 |