Cleared Special

Alinity i STAT High Sensitivity Troponin-I

K230994 · Abbott Laboratories Diagnostics Division · Chemistry
May 2023
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K230994 is an FDA 510(k) clearance for the Alinity i STAT High Sensitivity Troponin-I, a Immunoassay Method, Troponin Subunit (Class II — Special Controls, product code MMI), submitted by Abbott Laboratories Diagnostics Division (Abbott Park, US). The FDA issued a Cleared decision on May 4, 2023, 27 days after receiving the submission on April 7, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K230994 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 2023
Decision Date May 04, 2023
Days to Decision 27 days
Submission Type Special
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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