FDA 510(k) Application Details - K071711

Device Classification Name	Antibodies,Saccharomyces Cerevisiae (S.Cerevisiae)   More FDA Info for this Device
510(K) Number	K071711
Device Name	Antibodies,Saccharomyces Cerevisiae (S.Cerevisiae)
Applicant	TECHLAB INC., CORPORATE RESEARCH CENTER 2001 KRAFT DR. BLACKSBURG, VA 24060-6358 US Other 510(k) Applications for this Company
Contact	CHARLES PENNINGTON Other 510(k) Applications for this Contact
Regulation Number	866.5785   More FDA Info for this Regulation Number
Classification Product Code	NBT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/22/2007
Decision Date	11/07/2007
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