Cleared Traditional

MTS Imipenem 0.016-256 ?g/mL

K191908 · Liofilchem S. R. L. · Microbiology
Sep 2019
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K191908 is an FDA 510(k) clearance for the MTS Imipenem 0.016-256 ?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 September 4, 2019, 50 days after receiving the submission on July 16, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K191908 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2019
Decision Date September 04, 2019
Days to Decision 50 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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