Cleared Traditional

MTS Ceftobiprole 0.002-32 ?g/mL

K243202 · Liofilchem S. R. L. · Microbiology
Jan 2025
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K243202 is an FDA 510(k) clearance for the MTS Ceftobiprole 0.002-32 ?g/mL, a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Liofilchem S. R. L. (Roseto Degli Abruzzi (Te), IT). The FDA issued a Cleared decision on January 30, 2025, 121 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 K243202 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2024
Decision Date January 30, 2025
Days to Decision 121 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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