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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 K122420
Device Name DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA
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 Code
JJX  
Date Received08/09/2012
Decision Date 11/28/2012
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
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