IMMUNOCOMB(TM) TOXOPLASMA IGG ANTIBODY TEST KIT— 510(k) K885344

Substantially Equivalent

Orgenics, Ltd.

FDA 510(k) clearance K885344 for IMMUNOCOMB(TM) TOXOPLASMA IGG ANTIBODY TEST KIT, Substantially Equivalent on 1989-04-12. Applicant: Orgenics, Ltd..

Clearance details

Applicant: Orgenics, Ltd.
Product code: Code LGD
Advisory panel: Microbiology
Date received: 1988-12-28
Decision date: 1989-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.