FDA 510(k) Application Details - K982639

Device Classification Name	Igm (Mu Chain Specific), Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K982639
Device Name	Igm (Mu Chain Specific), Antigen, Antiserum, Control
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	866.5550   More FDA Info for this Regulation Number
Classification Product Code	DAO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/29/1998
Decision Date	11/04/1998
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