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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K102638
Device Name DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS
Applicant
Diazyme Laboratories
12889 Gregg Court
Poway,  CA  92064
Applicant Contact Abhijit Datta
Correspondent
Diazyme Laboratories
12889 Gregg Court
Poway,  CA  92064
Correspondent Contact Abhijit Datta
Regulation Number862.1150
Classification Product Code
JIT  
Date Received09/14/2010
Decision Date 11/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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