Cleared Traditional

MTS Doxycycline 0.016 - 256 ?g/mL

K190914 · Liofilchem S. R. L. · Microbiology
May 2019
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K190914 is an FDA 510(k) clearance for the MTS Doxycycline 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 May 29, 2019, 51 days after receiving the submission on April 8, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K190914 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 2019
Decision Date May 29, 2019
Days to Decision 51 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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