MTS Omadacycline 0.002 - 32 Ug/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 Ug/ml.

Pre-market Notification Details

Device IDK200180
510k NumberK200180
Device Name:MTS Omadacycline 0.002 - 32 Ug/mL
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant Liofilchem S. R. L. Via Scozia Zona Ind.le Roseto Degli Abruzzi,  IT 64026
ContactFabio Brocco
CorrespondentAnne R. Windau
Laboratory Specialists, Inc 26214 Center Ridge Road Westlake,  OH  44145
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyMicrobiology
510k Review PanelMicrobiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-24
Decision Date2020-03-20

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