SEKURE Acetaminophen L3K Assay— 510(k) K180835

Name: FDA 510(k) clearance K180835
Creator: U.S. Food and Drug Administration
Published: 2019-02-08

Substantially Equivalent

Sekisui Diagnostics P.E.I., Inc.

FDA 510(k) clearance K180835 for SEKURE Acetaminophen L3K Assay, Substantially Equivalent on 2019-02-08. Applicant: Sekisui Diagnostics P.E.I., Inc.. Device class: 2.

Clearance details

Applicant: Sekisui Diagnostics P.E.I., Inc.
Product code: Code LDP
Device class: Class 2
Regulation: 21 CFR 862.3030
Advisory panel: Clinical Toxicology
Date received: 2018-03-30
Decision date: 2019-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown,, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code LDP

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K261364 — Atellica CH Acetaminophen 2 (ACTM)2026-07-24
K202644 — Acetaminophen2022-02-18
K110726 — ROCHE ACETAMINOPHEN ASSAY2011-12-23
K100200 — ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 079891382010-08-02
K081938 — ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-302009-05-01

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K182702 — SEKURE Creatine Kinase Assay2019-04-17
K173206 — SEKURE HbA1c Assay2018-07-12
K163078 — DC-UIBC-CAL2016-12-08
K111915 — MAGNESIUM ASSAY2011-12-02

Adverse events under product code LDP

product code LDP

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.