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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Susceptibility Test Plate, Antifungal
510(k) Number K040560
Device Name ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING
Applicant
AB BIODISK
DALVAGEN 10
SOLNA,  SE 16956
Applicant Contact ANNE BOLMSTROM
Correspondent
AB BIODISK
DALVAGEN 10
SOLNA,  SE 16956
Correspondent Contact ANNE BOLMSTROM
Regulation Number866.1640
Classification Product Code
NGZ  
Date Received03/03/2004
Decision Date 07/27/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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