FDA 510(k) Application Details - K191316

Device Classification Name	Bromcresol Green Dye-Binding, Albumin   More FDA Info for this Device
510(K) Number	K191316
Device Name	Bromcresol Green Dye-Binding, Albumin
Applicant	Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626 US Other 510(k) Applications for this Company
Contact	Darlene Phillips Other 510(k) Applications for this Contact
Regulation Number	862.1035   More FDA Info for this Regulation Number
Classification Product Code	CIX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/15/2019
Decision Date	06/07/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review