Cleared Traditional

Atellica? IM High-Sensitivity Troponin I (TnIH)

K241165 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Jul 2024
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K241165 is an FDA 510(k) clearance for the Atellica? IM High-Sensitivity Troponin I (TnIH), a Immunoassay Method, Troponin Subunit (Class II — Special Controls, product code MMI), submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on July 25, 2024, 90 days after receiving the submission on April 26, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K241165 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2024
Decision Date July 25, 2024
Days to Decision 90 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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