FDA 510(k) Application Details - K172745

Device Classification Name	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control   More FDA Info for this Device
510(K) Number	K172745
Device Name	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant	IMMCO Diagnostics, Inc. 60 Pineview Dr. Buffalo, NY 14228 US Other 510(k) Applications for this Company
Contact	Kevin Lawson Other 510(k) Applications for this Contact
Regulation Number	866.5100   More FDA Info for this Regulation Number
Classification Product Code	DHN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/12/2017
Decision Date	06/05/2018
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