DETECTADOT SYSTEM 2000 TOXO IGG TEST— 510(k) K875109

Substantially Equivalent

Gull Laboratories, Inc.

FDA 510(k) clearance K875109 for DETECTADOT SYSTEM 2000 TOXO IGG TEST, Substantially Equivalent on 1988-03-07. Applicant: Gull Laboratories, Inc..

Clearance details

Applicant: Gull Laboratories, Inc.
Product code: Code LGD
Advisory panel: Microbiology
Date received: 1987-12-14
Decision date: 1988-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, 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.