Cleared Traditional

Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 ?g/mL

K172109 · Liofilchem S. R. L. · Microbiology
Sep 2017
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K172109 is an FDA 510(k) clearance for the Liofilchem MIC Test Strip (MTS), Erythromycin 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 27, 2017, 76 days after receiving the submission on July 13, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K172109 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 2017
Decision Date September 27, 2017
Days to Decision 76 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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