Cleared Traditional

Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 ?g) AZA50

K250789 · Thermo Fisher Scientific (Oxoid Ltd.) · Microbiology

Jun 2025

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K250789 is an FDA 510(k) clearance for the Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 ?g) AZA50, a Susceptibility Test Discs, Antimicrobial (Class II — Special Controls, product code JTN), submitted by Thermo Fisher Scientific (Oxoid Ltd.) (Basingstroke, GB). The FDA issued a Cleared decision on June 12, 2025, 90 days after receiving the submission on March 14, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number	K250789 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 14, 2025
Decision Date	June 12, 2025
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement