FDA 510(k) Application Details - K162200

Device Classification Name	Photometric Method, Magnesium   More FDA Info for this Device
510(K) Number	K162200
Device Name	Photometric Method, Magnesium
Applicant	RANDOX LABORATORIES LTD 55 DIAMOND ROAD CRUMLIN BT29 4QY GB Other 510(k) Applications for this Company
Contact	PAULINE 0 ARMSTRONG Other 510(k) Applications for this Contact
Regulation Number	862.1495   More FDA Info for this Regulation Number
Classification Product Code	JGJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/05/2016
Decision Date	04/28/2017
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