Cleared Traditional

Alinity i Total ?-hCG Reagent Kit, GLP systems Track

K230937 · Abbott Laboratories · Chemistry
Jun 2023
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K230937 is an FDA 510(k) clearance for the Alinity i Total ?-hCG Reagent Kit, GLP systems Track, 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 June 5, 2023, 63 days after receiving the submission on April 3, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K230937 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2023
Decision Date June 05, 2023
Days to Decision 63 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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