CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM— 510(k) K020828

Name: FDA 510(k) clearance K020828
Creator: U.S. Food and Drug Administration
Published: 2002-07-24

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K020828 for CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM, Substantially Equivalent on 2002-07-24. Applicant: Bayer Corp.. Device class: 2.

Clearance details

Applicant: Bayer Corp.
Product code: Code LTK
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 2002-03-14
Decision date: 2002-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K020828

K-number listed on FDA's recall record

Z-1486-2018 — ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)Class II·Terminated·Siemens Healthcare Diagnostics, Inc·20180221

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K020828.

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