FDA 510(k) Application Details - K091455

Device Classification Name	Test,System,Potassium,Enzymatic Method   More FDA Info for this Device
510(K) Number	K091455
Device Name	Test,System,Potassium,Enzymatic Method
Applicant	DIAZYME LABORATORIES 12889 GREGG COURT POWAY, CA 92064 US Other 510(k) Applications for this Company
Contact	Abhijit Datta Other 510(k) Applications for this Contact
Regulation Number	862.1600   More FDA Info for this Regulation Number
Classification Product Code	MZV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/18/2009
Decision Date	08/14/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review