FDA 510(k) Application Details - K991316

Device Classification Name	Ige, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K991316
Device Name	Ige, Antigen, Antiserum, Control
Applicant	TOUCH SCIENTIFIC, INC. 3209 GRESHAM LAKE RD. SUITE 112 RALEIGH, NC 27615 US Other 510(k) Applications for this Company
Contact	ALAN J TOUCH Other 510(k) Applications for this Contact
Regulation Number	866.5510   More FDA Info for this Regulation Number
Classification Product Code	DGC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/19/1999
Decision Date	08/09/1999
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