FDA 510(k) Application Details - K984145

Device Classification Name	Myoglobin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K984145
Device Name	Myoglobin, Antigen, Antiserum, Control
Applicant	OLYMPUS DIAGNOSTICA GMBH TWO CORPORATE CENTER DR. MELVILLE, NY 11747 US Other 510(k) Applications for this Company
Contact	LAURA STORMS-TYLER 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	11/19/1998
Decision Date	12/23/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review