FDA 510(k) Application Details - K042189

Device Classification Name	System,Test,Sodium,Enzymatic Method   More FDA Info for this Device
510(K) Number	K042189
Device Name	System,Test,Sodium,Enzymatic Method
Applicant	DIAZYME LABORATORIES 3550 GENERAL ATOMICS CT. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	HUHAN TRAN Other 510(k) Applications for this Contact
Regulation Number	862.1665   More FDA Info for this Regulation Number
Classification Product Code	MZU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/12/2004
Decision Date	10/07/2004
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