Cortisol Saliva Luminescence Immunoassay— 510(k) K150528

Name: FDA 510(k) clearance K150528
Creator: U.S. Food and Drug Administration
Published: 2015-11-25

Substantially Equivalent

Ibl International GmbH

FDA 510(k) clearance K150528 for Cortisol Saliva Luminescence Immunoassay, Substantially Equivalent on 2015-11-25. Applicant: Ibl International GmbH. Device class: 2.

Clearance details

Applicant: Ibl International GmbH
Product code: Code NHG
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 2015-03-02
Decision date: 2015-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamburg, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code NHG

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K102841 — PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY2012-05-08
K070788 — ELECSYS CORTISOL TEST SYSTEM2007-10-05
K051733 — ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL2005-12-07
K043175 — ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE2004-11-24
K031348 — HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY2003-06-10

Recalls naming K150528

K-number listed on FDA's recall record

Z-2923-2018 — Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva and for use as an aid in the diagnosis and treatment of adrenal disorders. The device is not intended for point-of-care settings.Class II·Terminated·Tecan US, Inc.·20180112

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150528.

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