FDA 510(k) Application Details - DEN040003

Device Classification Name	Antigen, Invasive Fungal Pathogens   More FDA Info for this Device
510(K) Number	DEN040003
Device Name	Antigen, Invasive Fungal Pathogens
Applicant	ASSOCIATES OF CAPE COD, INC. 1738 TAMBERWOOD ECHO WOODBURY, MN 55125 US Other 510(k) Applications for this Company
Contact	STACY SUBERG Other 510(k) Applications for this Contact
Regulation Number	866.3050   More FDA Info for this Regulation Number
Classification Product Code	NQZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/22/2004
Decision Date	05/21/2004
Decision	DENG -
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review