FDA 510(k) Application Details - K981048

Device Classification Name	Immunoelectrophoretic, Immunoglobulins, (G, A, M)   More FDA Info for this Device
510(K) Number	K981048
Device Name	Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Applicant	MORAX 13805 WATERLOO RD. CHELSEA, MI 48118 US Other 510(k) Applications for this Company
Contact	BOREK JANIK, PH.D. Other 510(k) Applications for this Contact
Regulation Number	866.5510   More FDA Info for this Regulation Number
Classification Product Code	CFF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/20/1998
Decision Date	10/07/1998
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