Lumipulse G CA19-9-N— 510(k) K200997

Substantially Equivalent

Fujirebio Diagnostics,Inc.

FDA 510(k) clearance K200997 for Lumipulse G CA19-9-N, Substantially Equivalent on 2020-05-14. Applicant: Fujirebio Diagnostics,Inc..

Clearance details

Applicant: Fujirebio Diagnostics,Inc.
Product code: Code NIG
Advisory panel: Immunology
Date received: 2020-04-16
Decision date: 2020-05-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NIG

product code NIG

Malfunction: 618
Total: 618

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.