ETEST MEROPENEM

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 Meropenem.

Pre-market Notification Details

Device IDK010363
510k NumberK010363
Device Name:ETEST MEROPENEM
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 Received2001-02-07
Decision Date2001-04-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026378165 K010363 000
03573026259280 K010363 000
03573026618766 K010363 000

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