ETEST MOXIFLOXACIN

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 Moxifloxacin.

Pre-market Notification Details

Device IDK000298
510k NumberK000298
Device Name:ETEST MOXIFLOXACIN
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 Received2000-01-31
Decision Date2000-05-18

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