Cleared Traditional

MTS Omadacycline 0.002 - 32 ug/mL

K200180 · Liofilchem S. R. L. · Microbiology
Mar 2020
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K200180 is an FDA 510(k) clearance for the MTS Omadacycline 0.002 - 32 ug/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 March 20, 2020, 56 days after receiving the submission on January 24, 2020. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K200180 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 2020
Decision Date March 20, 2020
Days to Decision 56 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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