Cleared Traditional

Access hsTnI

K222881 · Beckman Coulter, Inc. · Chemistry
Dec 2023
Decision
452d
Days
Class 2
Risk

About This 510(k) Submission

K222881 is an FDA 510(k) clearance for the Access hsTnI, a Immunoassay Method, Troponin Subunit (Class II — Special Controls, product code MMI), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on December 18, 2023, 452 days after receiving the submission on September 22, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K222881 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2022
Decision Date December 18, 2023
Days to Decision 452 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MMI — Immunoassay Method, Troponin Subunit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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