FDA 510(k) Application Details - K011566

Device Classification Name	Autoantibodies, Endomysial(Tissue Transglutaminase)   More FDA Info for this Device
510(K) Number	K011566
Device Name	Autoantibodies, Endomysial(Tissue Transglutaminase)
Applicant	INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. SAN DIEGO, CA 92131-1234 US Other 510(k) Applications for this Company
Contact	BRYS C MYERS Other 510(k) Applications for this Contact
Regulation Number	866.5660   More FDA Info for this Regulation Number
Classification Product Code	MVM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/21/2001
Decision Date	07/09/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review