Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60— 510(k) K261781

Name: FDA 510(k) clearance K261781
Creator: U.S. Food and Drug Administration
Published: 2026-07-24

Substantially Equivalent

Thermo 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.

Clearance details

Applicant: Thermo Fisher Scientific (Oxoid Ltd.)
Product code: Code JTN
Device class: Class 2
Regulation: 21 CFR 866.1620
Advisory panel: Microbiology
Date received: 2026-05-29
Decision date: 2026-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Basingstoke, GB

Download summary PDF View on FDA.gov ↗

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