VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT— 510(k) K101921

Substantially Equivalent

Ortho-Clinical Diagnostics

FDA 510(k) clearance K101921 for VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT, Substantially Equivalent on 2010-10-22. Applicant: Ortho-Clinical Diagnostics.

Clearance details

Applicant: Ortho-Clinical Diagnostics
Product code: Code CEW
Advisory panel: Clinical Chemistry
Date received: 2010-07-09
Decision date: 2010-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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.