FDA 510(k) Application Details - K972513

Device Classification Name	Myoglobin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K972513
Device Name	Myoglobin, Antigen, Antiserum, Control
Applicant	BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. CONCORD, CA 94524 US Other 510(k) Applications for this Company
Contact	Yvette Lloyd Other 510(k) Applications for this Contact
Regulation Number	866.5680   More FDA Info for this Regulation Number
Classification Product Code	DDR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/07/1997
Decision Date	07/28/1997
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