Cleared Traditional

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL

K242659 · Thermo Fisher Scientific · Microbiology
May 2025
Decision
260d
Days
Class 2
Risk

About This 510(k) Submission

K242659 is an FDA 510(k) clearance for the The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 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 May 22, 2025, 260 days after receiving the submission on September 4, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K242659 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 2024
Decision Date May 22, 2025
Days to Decision 260 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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