FDA 510(k) Application Details - K140225

Device Classification Name	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)   More FDA Info for this Device
510(K) Number	K140225
Device Name	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Applicant	PHADIA US INC. MUNZINGER STRASSE 7 FREIBURG IM BREISGAU 79111 DE Other 510(k) Applications for this Company
Contact	MARTIN MANN Other 510(k) Applications for this Contact
Regulation Number	866.5660   More FDA Info for this Regulation Number
Classification Product Code	MOB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/29/2014
Decision Date	10/27/2014
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