AMOXICILLIN/CLAVULANIC ACID 2/1

Manual Antimicrobial Susceptibility Test Systems

AB BIODISK NORTH AMERICA, INC.

The following data is part of a premarket notification filed by Ab Biodisk North America, Inc. with the FDA for Amoxicillin/clavulanic Acid 2/1.

Pre-market Notification Details

Device IDK950328
510k NumberK950328
Device Name:AMOXICILLIN/CLAVULANIC ACID 2/1
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant AB BIODISK NORTH AMERICA, INC. PYRAMIDVAGEN, 7 S-17136 Solna, Sweden,  SE
ContactAnne Bolmstrom
CorrespondentAnne Bolmstrom
AB BIODISK NORTH AMERICA, INC. PYRAMIDVAGEN, 7 S-17136 Solna, Sweden,  SE
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-19
Decision Date1995-04-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026376581 K950328 000
03573026252328 K950328 000
03573026623609 K950328 000

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