FDA 510(k) Application Details - K191085

Device Classification Name	Anti-Rnp Antibody, Antigen And Control   More FDA Info for this Device
510(K) Number	K191085
Device Name	Anti-Rnp Antibody, Antigen And Control
Applicant	Genalyte, Inc. 10520 Wateridge Circle San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Rick Hockett Other 510(k) Applications for this Contact
Regulation Number	866.5100   More FDA Info for this Regulation Number
Classification Product Code	LKO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/24/2019
Decision Date	10/25/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review