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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Vitamin D
510(k) Number K102432
Device Name DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL,
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 Number862.1825
Classification Product Code
MRG  
Subsequent Product Codes
JIS   JJX  
Date Received08/26/2010
Decision Date 01/14/2011
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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