FDA 510(k) Application Details - K182042

Device Classification Name	Azo Dye, Calcium   More FDA Info for this Device
510(K) Number	K182042
Device Name	Azo Dye, Calcium
Applicant	Randox Laboratories Ltd. 55 Diamond Road Crumlin BT29 4QY GB Other 510(k) Applications for this Company
Contact	Pauline Armstrong Other 510(k) Applications for this Contact
Regulation Number	862.1145   More FDA Info for this Regulation Number
Classification Product Code	CJY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/30/2018
Decision Date	10/23/2018
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