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510(k) K163418

Diazyme DZ-Lite Total beta-hCG Test System by Diazyme Laboratories — Product Code DHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2017
Date Received
December 6, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Human Chorionic Gonadotropin
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

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