K261781
- 510(k) number
- K261781
- Device name
- Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60
- Applicant
- Thermo Fisher Scientific (Oxoid Ltd.) GB
- Product code
- JTN — Susceptibility Test Discs, Antimicrobial
- Decision date
- 2026-07-24
- Date received
- 2026-05-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K261781
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.