Cleared Traditional

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL

K242653 · Thermo Fisher Scientific · Microbiology
Dec 2024
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K242653 is an FDA 510(k) clearance for the The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 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 December 5, 2024, 92 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 K242653 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 2024
Decision Date December 05, 2024
Days to Decision 92 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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