FDA 510(k) Application Details - K141375

Device Classification Name	Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control   More FDA Info for this Device
510(K) Number	K141375
Device Name	Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant	PHADIA US INC. MUNZINGER STRASSE 7 FREIBURG IM BREISGAU 79111 DE Other 510(k) Applications for this Company
Contact	MANUELA CONSTANZE HOG Other 510(k) Applications for this Contact
Regulation Number	866.5090   More FDA Info for this Regulation Number
Classification Product Code	DBM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/27/2014
Decision Date	02/13/2015
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