FDA 510(k) Application Details - K971833

Device Classification Name	Radioimmunoassay (Two-Site Solid Phase), Ferritin   More FDA Info for this Device
510(K) Number	K971833
Device Name	Radioimmunoassay (Two-Site Solid Phase), Ferritin
Applicant	BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. P.O. BOX 50457 INDIANAPOLIS, IN 46250-0457 US Other 510(k) Applications for this Company
Contact	LEEANN CHAMBERS Other 510(k) Applications for this Contact
Regulation Number	866.5340   More FDA Info for this Regulation Number
Classification Product Code	JMG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/19/1997
Decision Date	06/02/1997
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