Cleared Traditional

The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL

K243201 · Thermo Fisher Scientific · Microbiology
Feb 2025
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K243201 is an FDA 510(k) clearance for the The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 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 February 10, 2025, 132 days after receiving the submission on October 1, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K243201 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2024
Decision Date February 10, 2025
Days to Decision 132 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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