TOXOPLASMA GONDII IGG ELISA— 510(k) K871905

Substantially Equivalent

Electro-Nucleonics Laboratories, Inc.

FDA 510(k) clearance K871905 for TOXOPLASMA GONDII IGG ELISA, Substantially Equivalent on 1987-07-30. Applicant: Electro-Nucleonics Laboratories, Inc..

Clearance details

Applicant: Electro-Nucleonics Laboratories, Inc.
Product code: Code LGD
Advisory panel: Microbiology
Date received: 1987-05-15
Decision date: 1987-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, 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.