Cleared Traditional

SEKURE Acetaminophen L3K Assay

K180835 · Sekisui Diagnostics P.E.I., Inc. · Toxicology
Feb 2019
Decision
315d
Days
Class 2
Risk

About This 510(k) Submission

K180835 is an FDA 510(k) clearance for the SEKURE Acetaminophen L3K Assay, a Colorimetry, Acetaminophen (Class II — Special Controls, product code LDP), submitted by Sekisui Diagnostics P.E.I., Inc. (Charlottetown,, CA). The FDA issued a Cleared decision on February 8, 2019, 315 days after receiving the submission on March 30, 2018. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3030.

Submission Details

510(k) Number K180835 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2018
Decision Date February 08, 2019
Days to Decision 315 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LDP — Colorimetry, Acetaminophen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3030

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