MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT— 510(k) K884249

Substantially Equivalent

Disease Detection International, Inc.

FDA 510(k) clearance K884249 for MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT, Substantially Equivalent on 1989-04-10. Applicant: Disease Detection International, Inc..

Clearance details

Applicant: Disease Detection International, Inc.
Product code: Code LGD
Advisory panel: Microbiology
Date received: 1988-10-11
Decision date: 1989-04-10
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.