ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING

Susceptibility Test Plate, Antifungal

AB BIODISK

The following data is part of a premarket notification filed by Ab Biodisk with the FDA for Etest For Antifungal Suscepttibility Testing.

Pre-market Notification Details

Device IDK040560
510k NumberK040560
Device Name:ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING
ClassificationSusceptibility Test Plate, Antifungal
Applicant AB BIODISK DALVAGEN 10 Solna,  SE 16956
ContactAnne Bolmstrom
CorrespondentAnne Bolmstrom
AB BIODISK DALVAGEN 10 Solna,  SE 16956
Product CodeNGZ  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-03-03
Decision Date2004-07-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026616014 K040560 000
03573026377717 K040560 000
03573026252885 K040560 000
03573026253318 K040560 000
03573026623562 K040560 000

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