FDA 510(k) Application Details - K172078

Device Classification Name	Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody   More FDA Info for this Device
510(K) Number	K172078
Device Name	Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody
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	NYO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/10/2017
Decision Date	03/30/2018
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