Home / 510(k) Clearances / K230790

510(k) K230790

Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series by Abbott Laboratories — Product Code DHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2023
Date Received
March 22, 2023
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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