FDA 510(k) Application Details - K040560

Device Classification Name	Susceptibility Test Plate, Antifungal   More FDA Info for this Device
510(K) Number	K040560
Device Name	Susceptibility Test Plate, Antifungal
Applicant	AB BIODISK DALVAGEN 10 SOLNA 16956 SE Other 510(k) Applications for this Company
Contact	ANNE BOLMSTROM Other 510(k) Applications for this Contact
Regulation Number	866.1640   More FDA Info for this Regulation Number
Classification Product Code	NGZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/03/2004
Decision Date	07/27/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review