FDA 510(k) Application Details - K964301

Device Classification Name	Haptoglobin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K964301
Device Name	Haptoglobin, Antigen, Antiserum, Control
Applicant	CRESTAT DIAGNOSTICS, INC. 25549 ADAMS AVE. MURRIETA, CA 92562 US Other 510(k) Applications for this Company
Regulation Number	866.5460   More FDA Info for this Regulation Number
Classification Product Code	DAD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/29/1996
Decision Date	07/14/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review