ELEGANCE NEONATAL TSH ELISA— 510(k) K935049

Substantially Equivalent

Bioclone Australia Pty , Ltd.

FDA 510(k) clearance K935049 for ELEGANCE NEONATAL TSH ELISA, Substantially Equivalent on 1994-10-03. Applicant: Bioclone Australia Pty , Ltd..

Clearance details

Applicant: Bioclone Australia Pty , Ltd.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1993-10-20
Decision date: 1994-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JLW

product code JLW

Malfunction: 885
Total: 885

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.