FDA 510(k) Application Details - K974881

Device Classification Name	Antigen, C. Difficile   More FDA Info for this Device
510(K) Number	K974881
Device Name	Antigen, C. Difficile
Applicant	BIOSITE INCORPORATED 11030 ROSELLE ST. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	JOHN F BRUNI Other 510(k) Applications for this Contact
Regulation Number	866.2660   More FDA Info for this Regulation Number
Classification Product Code	MCB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/1997
Decision Date	03/20/1998
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