BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY— 510(k) K003291

Name: FDA 510(k) clearance K003291
Creator: U.S. Food and Drug Administration
Published: 2000-12-05

Substantially Equivalent

Bayer Diagnostics Corp.

FDA 510(k) clearance K003291 for BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY, Substantially Equivalent on 2000-12-05. Applicant: Bayer Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: Code JZO
Device class: Class 2
Regulation: 21 CFR 866.5870
Advisory panel: Immunology
Date received: 2000-10-20
Decision date: 2000-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medfield, MA, US

Download summary PDF View on FDA.gov ↗

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K031857 — ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY2003-09-04
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Recalls naming K003291

K-number listed on FDA's recall record

Z-3304-2024 — ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)Class II·Ongoing·Siemens Healthcare Diagnostics, Inc.·20240821
Z-3305-2024 — Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)Class II·Ongoing·Siemens Healthcare Diagnostics, Inc.·20240821

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K003291.

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