Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/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 Liofilchem Mic Test Strip (mts)- Linezolid 0.016 - 256ug/ml.

Pre-market Notification Details

Device IDK180330
510k NumberK180330
Device Name:Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/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 Received2018-02-06
Decision Date2018-03-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08055182873302 K180330 000

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