FDA 510(k) Application Details - K122302

Device Classification Name	Photometric Method, Magnesium   More FDA Info for this Device
510(K) Number	K122302
Device Name	Photometric Method, Magnesium
Applicant	ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC 4 HENDERSON DRIVE WEST CALDWELL, NJ 07006 US Other 510(k) Applications for this Company
Contact	HYMAN KATZ 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	08/01/2012
Decision Date	08/27/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review