FDA 510(k) Application Details - K963139

Device Classification Name	Transferrin, Rhodamine, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K963139
Device Name	Transferrin, Rhodamine, 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	866.5880   More FDA Info for this Regulation Number
Classification Product Code	DDD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/12/1996
Decision Date	02/06/1997
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