Cleared Traditional

Alinity i Total ?-hCG Reagent Kit, Alinity i System

K170317 · Abbott Laboratories · Chemistry
Oct 2017
Decision
264d
Days
Class 2
Risk

About This 510(k) Submission

K170317 is an FDA 510(k) clearance for the Alinity i Total ?-hCG Reagent Kit, Alinity i System, a System, Test, Human Chorionic Gonadotropin (Class II — Special Controls, product code DHA), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 23, 2017, 264 days after receiving the submission on February 1, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K170317 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2017
Decision Date October 23, 2017
Days to Decision 264 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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