FDA 510(k) Application Details - K130053

Device Classification Name	Autoantibodies, Endomysial(Tissue Transglutaminase)   More FDA Info for this Device
510(K) Number	K130053
Device Name	Autoantibodies, Endomysial(Tissue Transglutaminase)
Applicant	BIO-RAD LABORATORIES, INC. 5500 EAST 2ND ST. BENICIA, CA 94510 US Other 510(k) Applications for this Company
Contact	Juang Wang 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	01/15/2013
Decision Date	09/19/2013
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