MTS Omadacycline 0.002-32 µg/mL

Manual Antimicrobial Susceptibility Test Systems

Liofilchem S. R. L.

The following data is part of a premarket notification filed by Liofilchem S. R. L. with the FDA for Mts Omadacycline 0.002-32 µg/ml.

Pre-market Notification Details

Device IDK182922
510k NumberK182922
Device Name:MTS Omadacycline 0.002-32 µg/mL
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant Liofilchem S. R. L. Via Scozia Zona Ind.le Roseto Degli Abruzzi,  IT 64026
ContactFabio Brocco
CorrespondentLaura M. Koeth
Laboratory Specialists, Inc 26214 Center Ridge Road Westlake,  OH  44145
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-19
Decision Date2018-12-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.