FDA 510(k) Application Details - K193001

Device Classification Name	Bromcresol Purple Dye-Binding, Albumin   More FDA Info for this Device
510(K) Number	K193001
Device Name	Bromcresol Purple Dye-Binding, Albumin
Applicant	Sentinel CH. SpA Via Robert Koch, 2 Milano 20152 IT Other 510(k) Applications for this Company
Contact	Patricia Dupe Other 510(k) Applications for this Contact
Regulation Number	862.1035   More FDA Info for this Regulation Number
Classification Product Code	CJW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/28/2019
Decision Date	12/19/2019
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