Cleared Traditional

ARCHITECT STAT High Sensitivity Troponin-I

K191595 · Abbott Laboratories Diagnostics Division · Chemistry

Sep 2019

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K191595 is an FDA 510(k) clearance for the ARCHITECT 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 September 13, 2019, 88 days after receiving the submission on June 17, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number	K191595 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 17, 2019
Decision Date	September 13, 2019
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF