AMIZYME-TOXOPLASMA GONDII KIT— 510(k) K842528

Substantially Equivalent

Amico Lab, Inc.

FDA 510(k) clearance K842528 for AMIZYME-TOXOPLASMA GONDII KIT, Substantially Equivalent on 1984-09-07. Applicant: Amico Lab, Inc..

Clearance details

Applicant: Amico Lab, Inc.
Product code: Code LGD
Advisory panel: Microbiology
Date received: 1984-06-28
Decision date: 1984-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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.