FDA 510(k) Application Details - K081325

Device Classification Name	Manual Antimicrobial Susceptibility Test Systems   More FDA Info for this Device
510(K) Number	K081325
Device Name	Manual Antimicrobial Susceptibility Test Systems
Applicant	AB BIODISK DALVAGEN 10 SOLNA 16956 SE Other 510(k) Applications for this Company
Contact	ANETTE ENGELHARDT Other 510(k) Applications for this Contact
Regulation Number	866.1640   More FDA Info for this Regulation Number
Classification Product Code	JWY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/12/2008
Decision Date	07/24/2008
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