THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)F— 510(k) K984317

Substantially Equivalent

Zeus Scientific, Inc.

FDA 510(k) clearance K984317 for THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)F, Substantially Equivalent on 1999-01-22. Applicant: Zeus Scientific, Inc..

Clearance details

Applicant: Zeus Scientific, Inc.
Product code: Code LGD
Advisory panel: Microbiology
Date received: 1998-12-03
Decision date: 1999-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, 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.