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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, human chorionic gonadotropin
510(k) Number K163418
Device Name Diazyme DZ-Lite Total beta-hCG Test System
Applicant
Diazyme Laboratories
12889 Gregg Court
Poway,  CA  92130
Applicant Contact Abhijit Datta
Correspondent
Diazyme Laboratories
12889 Gregg Court
Poway,  CA  92130
Correspondent Contact Abhijit Datta
Regulation Number862.1155
Classification Product Code
DHA  
Subsequent Product Code
JJE  
Date Received12/06/2016
Decision Date 08/18/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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