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510(k) K230937

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2023
Date Received
April 3, 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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  • K212221 — Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemilu (December 13, 2021)
  • K203227 — Elecsys HCG STAT (August 18, 2021)
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  • K192790 — Atellica IM Total hCG (ThCG) (October 30, 2019)
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