ADVANTAGE HCG TEST (URINE/SERUM)— 510(k) K994227

Substantially Equivalent

Advantage Diagnostics Corp.

FDA 510(k) clearance K994227 for ADVANTAGE HCG TEST (URINE/SERUM), Substantially Equivalent on 2000-02-03. Applicant: Advantage Diagnostics Corp..

Clearance details

Applicant: Advantage Diagnostics Corp.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1999-12-15
Decision date: 2000-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountian View, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JHI

product code JHI

Malfunction: 1,055
Total: 1,055

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.