VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack— 510(k) K231525

Substantially Equivalent

Ortho Clinical Diagnostics

FDA 510(k) clearance K231525 for VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack, Substantially Equivalent on 2023-08-09. Applicant: Ortho Clinical Diagnostics.

Clearance details

Applicant: Ortho Clinical Diagnostics
Product code: Code NIG
Advisory panel: Immunology
Date received: 2023-05-26
Decision date: 2023-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgend, GB

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.