Cleared Traditional

MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 ?g/mL

K192345 · Liofilchem S. R. L. · Microbiology
Oct 2019
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K192345 is an FDA 510(k) clearance for the MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 ?g/mL, a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Liofilchem S. R. L. (Roseto Degli Abruzzi, IT). The FDA issued a Cleared decision on October 31, 2019, 63 days after receiving the submission on August 29, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K192345 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2019
Decision Date October 31, 2019
Days to Decision 63 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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