TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM— 510(k) K955760

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K955760 for TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM, Substantially Equivalent on 1996-08-02. Applicant: Bayer Corp..

Clearance details

Applicant: Bayer Corp.
Product code: Code LGD
Advisory panel: Microbiology
Date received: 1995-12-20
Decision date: 1996-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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.