Cleared Traditional

MTS Ciprofloxacin 0.002 - 32 ?g/mL

K183527 · Liofilchem S. R. L. · Microbiology
Mar 2019
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K183527 is an FDA 510(k) clearance for the MTS Ciprofloxacin 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 March 19, 2019, 90 days after receiving the submission on December 19, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K183527 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 2018
Decision Date March 19, 2019
Days to Decision 90 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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