Cleared Traditional

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL

K252014 · Thermo Fisher Scientific · Microbiology
Aug 2025
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K252014 is an FDA 510(k) clearance for the The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 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 August 28, 2025, 62 days after receiving the submission on June 27, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K252014 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2025
Decision Date August 28, 2025
Days to Decision 62 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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