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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 K082534
Device Name ETEST VORICONAZOLE 0.002-32 UG/ML
Applicant
Ab Biomerieux
Dalvagen 10
Solna,  SE 16956
Applicant Contact ANETTE ENGELHARDT
Correspondent
Ab Biomerieux
Dalvagen 10
Solna,  SE 16956
Correspondent Contact ANETTE ENGELHARDT
Regulation Number866.1640
Classification Product Code
NGZ  
Date Received09/02/2008
Decision Date 11/02/2009
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
Predetermined Change
Control Plan Authorized		 No
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