ETEST BENZYLPENICILLIN

Manual Antimicrobial Susceptibility Test Systems

AB BIODISK

The following data is part of a premarket notification filed by Ab Biodisk with the FDA for Etest Benzylpenicillin.

Pre-market Notification Details

Device IDK980335
510k NumberK980335
Device Name:ETEST BENZYLPENICILLIN
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant AB BIODISK DALVAGEN 10 Solna,  SE 16956
ContactAnne Bolmstrom
CorrespondentAnne Bolmstrom
AB BIODISK DALVAGEN 10 Solna,  SE 16956
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-28
Decision Date1998-06-15

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