FDA 510(k) Application Details - K990998

Device Classification Name	Immunoelectrophoretic, Immunoglobulins, (G, A, M)   More FDA Info for this Device
510(K) Number	K990998
Device Name	Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Applicant	HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 BEAUMONT, TX 77704 US Other 510(k) Applications for this Company
Contact	PAT FRANKS 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	03/25/1999
Decision Date	06/28/1999
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