FDA 510(k) Application Details - K984191

Device Classification Name	Myoglobin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K984191
Device Name	Myoglobin, Antigen, Antiserum, Control
Applicant	DADE BEHRING, INC. P.O. BOX 6101 GLASGOW BLDG. 500 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	866.5680   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	11/23/1998
Decision Date	12/10/1998
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