Cleared Traditional

MTS Aztreonam-Avibactam 0.016/4 - 256/4 ?g/mL

K252114 · Liofilchem S. R. L. · Microbiology
Oct 2025
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K252114 is an FDA 510(k) clearance for the MTS Aztreonam-Avibactam 0.016/4 - 256/4 ?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 October 2, 2025, 87 days after receiving the submission on July 7, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K252114 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2025
Decision Date October 02, 2025
Days to Decision 87 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

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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