Cleared Traditional

Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL.

K172542 · Liofilchem S. R. L. · Microbiology
Oct 2017
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K172542 is an FDA 510(k) clearance for the Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/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 October 23, 2017, 61 days after receiving the submission on August 23, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K172542 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2017
Decision Date October 23, 2017
Days to Decision 61 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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