FDA 510(k) Application Details - K962409

Device Classification Name	Complement C3, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K962409
Device Name	Complement C3, Antigen, Antiserum, Control
Applicant	OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. MELVILLE, NY 11747-3157 US Other 510(k) Applications for this Company
Contact	LAURA STORMS-TYLER Other 510(k) Applications for this Contact
Regulation Number	866.5240   More FDA Info for this Regulation Number
Classification Product Code	CZW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/1996
Decision Date	10/18/1996
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