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510(k) K170960

CoaguChek Vantus System by Roche Diagnostics — Product Code GJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 25, 2017
Date Received
March 31, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Time, Prothrombin
Device Class
Class II
Regulation Number
864.7750
Review Panel
HE
Submission Type

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