Thermo Fisher Scientific (Oxoid Ltd.) - FDA 510(k) Cleared Devices
Recent clearances: Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10, Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Thermo Fisher Scientific (Oxoid Ltd.) Microbiology ✕
3 devices
Cleared
Jul 24, 2026
Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60
Microbiology
56d
Cleared
Dec 05, 2025
Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10
Microbiology
219d
Cleared
Jun 12, 2025
Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50
Microbiology
90d