FDA 510(k) Application Details - K032874

Device Classification Name	More FDA Info for this Device
510(K) Number	K032874
Device Name	HBA SPERM-HYALURONAN BINDING ASSAY
Applicant	BIOCOAT, INC. 455 PENNSYLVANIA AVE. FORT WASHINGTON, PA 19034 US Other 510(k) Applications for this Company
Contact	JAMES B JOHNSTON Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	POV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/15/2003
Decision Date	11/24/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review