FDA 510(k) Application Details - K111915

Device Classification Name	Photometric Method, Magnesium   More FDA Info for this Device
510(K) Number	K111915
Device Name	Photometric Method, Magnesium
Applicant	SEKISUI DIAGNOSTICS P.E.I. INC. 70 WATTS AVENUE CHARLOTTETOWN PRINCE EDWARD ISLAND C1E2B9 CA Other 510(k) Applications for this Company
Contact	PENNY J WHITE 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	07/06/2011
Decision Date	12/02/2011
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