ADVIA Centaur Cortisol (COR) Assy— 510(k) K142723

Name: FDA 510(k) clearance K142723
Creator: U.S. Food and Drug Administration
Published: 2015-03-31

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K142723 for ADVIA Centaur Cortisol (COR) Assy, Substantially Equivalent on 2015-03-31. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code JFT
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 2014-09-23
Decision date: 2015-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JFT

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K242505 — Elecsys Cortisol III2025-07-17
K192788 — ADVIA Centaur Cortisol (COR)2019-11-25
K152227 — Elecsys Cortisol II, Cortisol II CalSet2016-04-27
K062204 — ARCHITECT CORTISOL ASSAY2006-09-22
K033731 — AXSYM CORTISOL ASSAY2004-02-20

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Recalls naming K142723

K-number listed on FDA's recall record

Z-1504-2023 — Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and lithium heparin), and urine.Class II·Ongoing·Siemens Healthcare Diagnostics, Inc.·20230316

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142723.

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