FDA 510(k) Application Details - K021648

Device Classification Name	Antibodies, Anti-Actin, Anti-Smooth Muscle   More FDA Info for this Device
510(K) Number	K021648
Device Name	Antibodies, Anti-Actin, Anti-Smooth Muscle
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	866.5120   More FDA Info for this Regulation Number
Classification Product Code	NJF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/2002
Decision Date	09/20/2002
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