FDA 510(k) Application Details - K011396

Device Classification Name	Lactoferrin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K011396
Device Name	Lactoferrin, Antigen, Antiserum, Control
Applicant	TECHLAB, INC. 1861 PRATT DR., STE. 1030 BLACKSBURG, VA 24060-6364 US Other 510(k) Applications for this Company
Contact	DAVID M LYERLY Other 510(k) Applications for this Contact
Regulation Number	866.5570   More FDA Info for this Regulation Number
Classification Product Code	DEG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/07/2001
Decision Date	06/18/2001
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