510(k) K854024— CORNING MAGIC MAB HCG RADIOIMMUNOASSAY

Substantially Equivalent

Corning Medical & Scientific

Clearance details

Applicant: Corning Medical & Scientific
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1985-09-30
Decision date: 1985-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medfield, MA, US

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.