FDA 510(k) Application Details - K061296

Device Classification Name	Urinary Homocystine (Nonquantitative) Test System   More FDA Info for this Device
510(K) Number	K061296
Device Name	Urinary Homocystine (Nonquantitative) Test System
Applicant	DIAZYME LABORATORIES 3550 GENERAL ATOMICS CT. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	ROLAND STRICKLAND Other 510(k) Applications for this Contact
Regulation Number	862.1377   More FDA Info for this Regulation Number
Classification Product Code	LPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/09/2006
Decision Date	06/13/2006
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