GTN — Antisera, Fluorescent, All Types, Staphylococcus Spp. Class I
FDA product code GTN covers "Antisera, Fluorescent, All Types, Staphylococcus Spp.", a Class I medical device regulated under 21 CFR 866.3700. Submissions are reviewed by the Microbiology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GTN
- Device Class
- Class I
- Regulation Number
- 866.3700
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K855236 | oxoid u.s.a | DIAGNOSTIC REAGENT TST-RPLA | November 4, 1986 |
| K855233 | oxoid u.s.a | DIAGNOSTIC REAGENT SET-RPLA | November 4, 1986 |
| K851949 | wellcome diagnostics | STAPHAUREX ZL30 | May 22, 1985 |
| K791453 | volu sol medical industries | AGGLUTINOTEST-STAPHYLOLISIN | September 24, 1979 |