Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10— 510(k) K251337
Substantially EquivalentThermo Fisher Scientific (Oxoid Ltd.)
FDA 510(k) clearance K251337 for Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10, Substantially Equivalent on 2025-12-05. Applicant: Thermo Fisher Scientific (Oxoid Ltd.).
Clearance details
- Applicant
- Thermo Fisher Scientific (Oxoid Ltd.)
- Product code
- Code JTN
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Basingstoke, GB
Data sourced from openFDA. This site is unofficial and independent of the FDA.