MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 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 Ampicillin-sulbactam 0.016/0.008 - 256/128 µg/ml.

Pre-market Notification Details

Device IDK192345
510k NumberK192345
Device Name:MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 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 R. Windau
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 Received2019-08-29
Decision Date2019-10-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
18055182871169 K192345 000
28055182871159 K192345 000
08055182871148 K192345 000

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