Cleared Traditional

Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL

K180330 · Liofilchem S. R. L. · Microbiology
Mar 2018
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K180330 is an FDA 510(k) clearance for the Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/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 15, 2018, 37 days after receiving the submission on February 6, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K180330 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 2018
Decision Date March 15, 2018
Days to Decision 37 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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