Cleared Traditional

MTS Eravacycline 0.002 - 32 ?g/mL

K182557 · Liofilchem S. R. L. · Microbiology
Nov 2018
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K182557 is an FDA 510(k) clearance for the MTS Eravacycline 0.002 - 32 ?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 November 2, 2018, 46 days after receiving the submission on September 17, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K182557 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 2018
Decision Date November 02, 2018
Days to Decision 46 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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