Cleared Traditional

The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL

K250575 · Thermo Fisher Scientific · Microbiology
Sep 2025
Decision
191d
Days
Class 2
Risk

About This 510(k) Submission

K250575 is an FDA 510(k) clearance for the The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL, a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Thermo Fisher Scientific (Oakwood Village, US). The FDA issued a Cleared decision on September 5, 2025, 191 days after receiving the submission on February 26, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K250575 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 2025
Decision Date September 05, 2025
Days to Decision 191 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code JWY — Manual Antimicrobial Susceptibility Test Systems
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640

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