GSI — Antigens, Slide And Tube, All Types, Listeria Monocytogenes Class I
FDA product code GSI covers "Antigens, Slide And Tube, 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
- GSI
- 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 |
|---|---|---|---|
| K840503 | scientific device laboratory | SDL LISTERIA MONOCYTOGENES CONTROL | March 23, 1984 |