FDA 510(k) Application Details - K091910

Device Classification Name	Photometric Method, Magnesium   More FDA Info for this Device
510(K) Number	K091910
Device Name	Photometric Method, Magnesium
Applicant	ABAXIS, INC. 3240 WHIPPLE RD. UNION CITY, CA 94587 US Other 510(k) Applications for this Company
Contact	Dennis M Bleile 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	06/25/2009
Decision Date	10/01/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review