ETEST SUBMISSION FOR CEFOTETAN

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 Submission For Cefotetan.

Pre-market Notification Details

Device IDK961517
510k NumberK961517
Device Name:ETEST SUBMISSION FOR CEFOTETAN
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant AB BIODISK DAVAGEN 10 S-171 36 Solna,  SE
ContactAnne Bolmstrom
CorrespondentAnne Bolmstrom
AB BIODISK DAVAGEN 10 S-171 36 Solna,  SE
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-04-22
Decision Date1996-07-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026262112 K961517 000

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