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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urinary Homocystine (Nonquantitative) Test System
510(k) Number K032012
Device Name HOMOCYSTEINE MICROTITER PLATE ASSAY
Applicant
Diazyme Laboratories
3722 Ave. Sausalito
Irvine,  CA  92606
Applicant Contact GREG HOLLAND
Correspondent
Diazyme Laboratories
3722 Ave. Sausalito
Irvine,  CA  92606
Correspondent Contact GREG HOLLAND
Regulation Number862.1377
Classification Product Code
LPS  
Subsequent Product Code
JJX  
Date Received06/30/2003
Decision Date 09/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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