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510(k) K203227

Elecsys HCG STAT by Roche Diagnostics — Product Code DHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2021
Date Received
November 2, 2020
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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