Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 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 Liofilchem Mic Test Strip (mts), Meropenem/vaborbactam 0.016/8 - 256/8 µg/ml.

Pre-market Notification Details

Device IDK173307
510k NumberK173307
Device Name:Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant Liofilchem S. R. L. Via Scozia Zona Ind.le Roseto Degli Abruzzi,  IT 64026
ContactFabio Brocco
CorrespondentAnne Windau
Laboratory Specialists, Inc 1651-A Crossings Parkway Westlake,  OH  44145
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-10-18
Decision Date2017-12-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08055182870301 K173307 000

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