SERODOT TOXOPLASMA IGG TEST KIT— 510(k) K875363

Substantially Equivalent

Disease Detection International, Inc.

FDA 510(k) clearance K875363 for SERODOT TOXOPLASMA IGG TEST KIT, Substantially Equivalent on 1988-04-21. Applicant: Disease Detection International, Inc..

Clearance details

Applicant: Disease Detection International, Inc.
Product code: Code LGD
Advisory panel: Microbiology
Date received: 1987-12-31
Decision date: 1988-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.