Cleared Traditional

MTS Tetracycline 0.016 - 256 ug/mL

K183140 · Liofilchem S. R. L. · Microbiology
Jan 2019
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K183140 is an FDA 510(k) clearance for the MTS Tetracycline 0.016 - 256 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 January 11, 2019, 59 days after receiving the submission on November 13, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K183140 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2018
Decision Date January 11, 2019
Days to Decision 59 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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