ETEST CIPROFLOXACIN

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 Ciprofloxacin.

Pre-market Notification Details

Device IDK981138
510k NumberK981138
Device Name:ETEST CIPROFLOXACIN
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 Received1998-03-30
Decision Date1998-06-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026377281 K981138 000
03573026252762 K981138 000
03573026618575 K981138 000

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