Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50— 510(k) K250789

Name: FDA 510(k) clearance K250789
Creator: U.S. Food and Drug Administration
Published: 2025-06-12

Substantially Equivalent

Thermo Fisher Scientific (Oxoid Ltd.)

FDA 510(k) clearance K250789 for Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50, Substantially Equivalent on 2025-06-12. 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: 2025-03-14
Decision date: 2025-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Basingstoke, GB

Download summary PDF View on FDA.gov ↗

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