FDA 510(k) Application Details - K061841

Device Classification Name	Radioassay, Intrinsic Factor Blocking Antibody   More FDA Info for this Device
510(K) Number	K061841
Device Name	Radioassay, Intrinsic Factor Blocking Antibody
Applicant	INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. SAN DIEGO, CA 92131-1638 US Other 510(k) Applications for this Company
Contact	GARY L NORMAN Other 510(k) Applications for this Contact
Regulation Number	862.1810   More FDA Info for this Regulation Number
Classification Product Code	LIG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/29/2006
Decision Date	12/22/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review