PIPERACILIN TAZOBACTAM 4 UG

Manual Antimicrobial Susceptibility Test Systems

AB BIODISK

The following data is part of a premarket notification filed by Ab Biodisk with the FDA for Piperacilin Tazobactam 4 Ug.

Pre-market Notification Details

Device IDK953223
510k NumberK953223
Device Name:PIPERACILIN TAZOBACTAM 4 UG
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant AB BIODISK DAVAGEN 10 S-171 36 Solna,  SE
ContactAnn Bolmstrom
CorrespondentAnn 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 Received1995-04-14
Decision Date1995-08-15

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