FDA 510(k) Application Details - K981536

Device Classification Name	Biosensor,Immunoassay,Myoglobin   More FDA Info for this Device
510(K) Number	K981536
Device Name	Biosensor,Immunoassay,Myoglobin
Applicant	HELLEN PROFESSIONAL SERVICES 9418 LASAINE AVE. NORTHRIDGE, CA 91325 US Other 510(k) Applications for this Company
Contact	ROBIN J HELLEN Other 510(k) Applications for this Contact
Regulation Number	866.5680   More FDA Info for this Regulation Number
Classification Product Code	MVE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/29/1998
Decision Date	06/29/1998
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