FDA 510(k) Application Details - K121053

Device Classification Name	Urinary Homocystine (Nonquantitative) Test System   More FDA Info for this Device
510(K) Number	K121053
Device Name	Urinary Homocystine (Nonquantitative) Test System
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	862.1377   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	04/06/2012
Decision Date	07/31/2012
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