Lumipulse G TSH-III Immunoreaction Cartridges— 510(k) K171103

Substantially Equivalent

Fujirebio Diagnostics,Inc.

FDA 510(k) clearance K171103 for Lumipulse G TSH-III Immunoreaction Cartridges, Substantially Equivalent on 2017-07-28. Applicant: Fujirebio Diagnostics,Inc..

Clearance details

Applicant: Fujirebio Diagnostics,Inc.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 2017-04-13
Decision date: 2017-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, 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.