ETEST FOR LEVOFLOXACIN

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 For Levofloxacin.

Pre-market Notification Details

Device IDK971697
510k NumberK971697
Device Name:ETEST FOR LEVOFLOXACIN
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 Received1997-05-08
Decision Date1997-07-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026378073 K971697 000
03573026253400 K971697 000
03573026623524 K971697 000

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