FDA 510(k) Application Details - K984326

Device Classification Name	Radioimmunoassay, Immunoglobulins (D, E)   More FDA Info for this Device
510(K) Number	K984326
Device Name	Radioimmunoassay, Immunoglobulins (D, E)
Applicant	BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250-0457 US Other 510(k) Applications for this Company
Contact	PRISCILLA A HAMILL Other 510(k) Applications for this Contact
Regulation Number	866.5510   More FDA Info for this Regulation Number
Classification Product Code	JHR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/03/1998
Decision Date	02/08/1999
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