Cleared Traditional

Alinity i STAT High Sensitivity Troponin-I

K202525 · Abbott Laboratories Diagnostics Division · Chemistry

May 2022

Decision

625d

Days

Class 2

Risk

About This 510(k) Submission

K202525 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 19, 2022, 625 days after receiving the submission on September 1, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number	K202525 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 01, 2020
Decision Date	May 19, 2022
Days to Decision	625 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF