DAPTOMYCIN

Manual Antimicrobial Susceptibility Test Systems

AB BIODISK

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

Pre-market Notification Details

Device IDK042392
510k NumberK042392
Device Name:DAPTOMYCIN
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 Received2004-09-02
Decision Date2004-12-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026376550 K042392 000
03573026253912 K042392 000
03573026619749 K042392 000

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