FDA 510(k) Application Details - K955908

Device Classification Name	Igm (Mu Chain Specific), Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K955908
Device Name	Igm (Mu Chain Specific), Antigen, Antiserum, Control
Applicant	BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. P.O. BOX 50457 INDIANAPOLIS, IN 46250-0457 US Other 510(k) Applications for this Company
Contact	JOHN D STEVENS Other 510(k) Applications for this Contact
Regulation Number	866.5550   More FDA Info for this Regulation Number
Classification Product Code	DAO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/29/1995
Decision Date	02/09/1996
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