Cholesterol2— 510(k) K203597

Name: FDA 510(k) clearance K203597
Creator: U.S. Food and Drug Administration
Published: 2022-06-30

Substantially Equivalent

Abbott Ireland Diagnostics Division

FDA 510(k) clearance K203597 for Cholesterol2, Substantially Equivalent on 2022-06-30. Applicant: Abbott Ireland Diagnostics Division. Device class: 1.

Clearance details

Applicant: Abbott Ireland Diagnostics Division
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 2020-12-09
Decision date: 2022-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longford, IE

Download summary PDF View on FDA.gov ↗

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K251091 — Lipids2025-12-30
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K190490 — VITROS XT Chemistry Products TRIG-CHOL Slides2019-03-27
K181373 — Extended Lipid Panel Assay2018-10-18
K180504 — Mission Lipid Panel Monitoring System2018-03-28

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