FDA 510(k) Application Details - K061508

Device Classification Name	More FDA Info for this Device
510(K) Number	K061508
Device Name	OSOM INFLUENZA A&B TEST
Applicant	GENZYME CORP. ONE KENDALL SQUARE CAMBRIDGE, MA 02139 US Other 510(k) Applications for this Company
Contact	FRED D LASKY Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PSZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2006
Decision Date	06/12/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review