BIOCLONE'S ELEGANCE HCG ELISA KIT— 510(k) K910420

Substantially Equivalent

Bioclone Australia Pty , Ltd.

FDA 510(k) clearance K910420 for BIOCLONE'S ELEGANCE HCG ELISA KIT, Substantially Equivalent on 1991-02-26. Applicant: Bioclone Australia Pty , Ltd..

Clearance details

Applicant: Bioclone Australia Pty , Ltd.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1991-01-30
Decision date: 1991-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.