Cleared Traditional

MTS Plazomicin 0.016-256 ?g/mL

K181708 · Liofilchem S. R. L. · Microbiology
Jul 2018
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K181708 is an FDA 510(k) clearance for the MTS Plazomicin 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 July 31, 2018, 33 days after receiving the submission on June 28, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K181708 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2018
Decision Date July 31, 2018
Days to Decision 33 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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