BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY— 510(k) K010755

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K010755 for BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY, Substantially Equivalent on 2001-08-20. Applicant: Bayer Corp..

Clearance details

Applicant: Bayer Corp.
Product code: Code LGD
Advisory panel: Microbiology
Date received: 2001-03-13
Decision date: 2001-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medfield, MA, US

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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.