AMOXICILLIN/CLAVULANIC ACID 2/1

Manual Antimicrobial Susceptibility Test Systems

AB BIODISK

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

Pre-market Notification Details

Device IDK954319
510k NumberK954319
Device Name:AMOXICILLIN/CLAVULANIC ACID 2/1
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant AB BIODISK DAVAGEN 10 S-171 36 Solna,  SE
ContactAnne Bolmstrom
CorrespondentAnne Bolmstrom
AB BIODISK DAVAGEN 10 S-171 36 Solna,  SE
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-09-13
Decision Date1995-12-12

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