Cleared Traditional

Access hsTnI

K243483 · Beckman Coulter, Inc. · Chemistry
Aug 2025
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K243483 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 August 1, 2025, 266 days after receiving the submission on November 8, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K243483 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2024
Decision Date August 01, 2025
Days to Decision 266 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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