TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)— 510(k) K971989

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K971989 for TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM), Substantially Equivalent on 1997-10-22. Applicant: Bayer Corp..

Clearance details

Applicant: Bayer Corp.
Product code: Code LGD
Advisory panel: Microbiology
Date received: 1997-05-29
Decision date: 1997-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, 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.