FDA 510(k) Application Details - K991136

Device Classification Name	System, Test, Beta-2-Microglobulin Immunological   More FDA Info for this Device
510(K) Number	K991136
Device Name	System, Test, Beta-2-Microglobulin Immunological
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	866.5630   More FDA Info for this Regulation Number
Classification Product Code	JZG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/05/1999
Decision Date	05/11/1999
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