Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60— 510(k) K261781
Substantially EquivalentThermo Fisher Scientific (Oxoid Ltd.)
FDA 510(k) clearance K261781 for Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60, Substantially Equivalent on 2026-07-24. Applicant: Thermo Fisher Scientific (Oxoid Ltd.). Device class: 2.
Summary
Thermo Fisher Scientific (Oxoid) is the applicant for the Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg), catalog FPZ60, filed under JTN, antimicrobial susceptibility test discs. The record gives no details beyond the name and code.
Class II, 21 CFR 866.1620. Microbiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
The applicant filed from Basingstoke, United Kingdom. The decision came 56 calendar days after receipt (May 29 to July 24, 2026).
Clearance details
- Applicant
- Thermo Fisher Scientific (Oxoid Ltd.)
- Product code
- Product code JTN
- Device class
- Class 2
- Regulation
- 21 CFR 866.1620
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Basingstoke, GB
Recent devices under product code JTN
view allMore clearances from Thermo Fisher Scientific (Oxoid Ltd.)
view allData sourced from openFDA. This site is unofficial and independent of the FDA.