Cleared Traditional

Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series

K230790 · Abbott Laboratories · Chemistry
May 2023
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K230790 is an FDA 510(k) clearance for the Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series, a System, Test, Human Chorionic Gonadotropin (Class II — Special Controls, product code DHA), submitted by Abbott Laboratories (Iriving, US). The FDA issued a Cleared decision on May 19, 2023, 58 days after receiving the submission on March 22, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K230790 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 2023
Decision Date May 19, 2023
Days to Decision 58 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DHA — System, Test, Human Chorionic Gonadotropin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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