Cleared Traditional

MTS Sulbactam-Durlobactam 0.004/4 - 64/4 ?g/mL (SUD)

K251580 · Liofilchem S. R. L. · Microbiology
Aug 2025
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K251580 is an FDA 510(k) clearance for the MTS Sulbactam-Durlobactam 0.004/4 - 64/4 ?g/mL (SUD), 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 August 20, 2025, 89 days after receiving the submission on May 23, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K251580 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 2025
Decision Date August 20, 2025
Days to Decision 89 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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