FDA 510(k) Application Details - K013282

Device Classification Name	Fab, Rhodamine, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K013282
Device Name	Fab, Rhodamine, Antigen, Antiserum, Control
Applicant	W. L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LN. FLAGSTAFF, AZ 86002-0500 US Other 510(k) Applications for this Company
Contact	R. LARRY PRATT Other 510(k) Applications for this Contact
Regulation Number	866.5520   More FDA Info for this Regulation Number
Classification Product Code	DBY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/02/2001
Decision Date	12/14/2001
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