FDA 510(k) Application Details - K001647

Device Classification Name	Nephelometer   More FDA Info for this Device
510(K) Number	K001647
Device Name	Nephelometer
Applicant	DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.O. BOX 6101, NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	REBECCA S AYASH Other 510(k) Applications for this Contact
Regulation Number	866.4540   More FDA Info for this Regulation Number
Classification Product Code	JZW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/30/2000
Decision Date	09/26/2000
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