VITROS Immunodiagnostic Products Intact PTH II Reagent Pack— 510(k) K221197

Substantially Equivalent

Ortho Clinical Diagnostics

FDA 510(k) clearance K221197 for VITROS Immunodiagnostic Products Intact PTH II Reagent Pack, Substantially Equivalent on 2023-09-05. Applicant: Ortho Clinical Diagnostics.

Clearance details

Applicant: Ortho Clinical Diagnostics
Product code: Code CEW
Advisory panel: Clinical Chemistry
Date received: 2022-04-25
Decision date: 2023-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgend, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code CEW

product code CEW

Malfunction: 480
Total: 480

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.