FDA 510(k) Application Details - DEN000007

Device Classification Name	Antibodies,Saccharomyces Cerevisiae (S.Cerevisiae)   More FDA Info for this Device
510(K) Number	DEN000007
Device Name	Antibodies,Saccharomyces Cerevisiae (S.Cerevisiae)
Applicant	INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. SAN DIEGO, CA 92131 US Other 510(k) Applications for this Company
Contact	BRYS C MYERS 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	07/18/2000
Decision Date	08/16/2000
Decision	DENG -
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review