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510(k) K170317

Alinity i Total ß-hCG Reagent Kit, Alinity i System by Abbott Laboratories — Product Code DHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2017
Date Received
February 1, 2017
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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