CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS— 510(k) K050202

Name: FDA 510(k) clearance K050202
Creator: U.S. Food and Drug Administration
Published: 2005-02-09

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K050202 for CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, Substantially Equivalent on 2005-02-09. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code CGR
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 2005-01-28
Decision date: 2005-02-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K050202

K-number listed on FDA's recall record

Z-2763-2019 — The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage: The assay is a paramagnetic particle, chemiluminescent immunoassay for the quanitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.Class II·Terminated·Beckman Coulter Inc.·20180918

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050202.

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