TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO— 510(k) K920702

Substantially Equivalent

Pharmacia Diagnostics, Inc.

FDA 510(k) clearance K920702 for TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO, Substantially Equivalent on 1992-07-08. Applicant: Pharmacia Diagnostics, Inc..

Clearance details

Applicant: Pharmacia Diagnostics, Inc.
Product code: Code LGD
Advisory panel: Microbiology
Date received: 1992-02-18
Decision date: 1992-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfield, NJ, 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.