FDA 510(k) Application Details - K974111

Device Classification Name	Complement C9, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K974111
Device Name	Complement C9, Antigen, Antiserum, Control
Applicant	QUIDEL CORP. 10165 MCKELLAR CT. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	Robin Weiner Other 510(k) Applications for this Contact
Regulation Number	866.5240   More FDA Info for this Regulation Number
Classification Product Code	DAE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/1997
Decision Date	07/29/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review