ETEST ERTAPENEM

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 Ertapenem.

Pre-market Notification Details

Device IDK020748
510k NumberK020748
Device Name:ETEST ERTAPENEM
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 Received2002-03-07
Decision Date2002-04-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026377533 K020748 000
03573026260439 K020748 000
03573026618599 K020748 000

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