BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY— 510(k) K012183

Name: FDA 510(k) clearance K012183
Creator: U.S. Food and Drug Administration
Published: 2001-12-27

Substantially Equivalent

Bayer Diagnostics Corp.

FDA 510(k) clearance K012183 for BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY, Substantially Equivalent on 2001-12-27. Applicant: Bayer Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: Code LGD
Device class: Class 2
Regulation: 21 CFR 866.3780
Advisory panel: Microbiology
Date received: 2001-07-12
Decision date: 2001-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medfield, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LGD

product code LGD

Malfunction: 502
Total: 502

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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