Ortho-Clinical Diagnostics, Inc.
Ortho-Clinical Diagnostics, Inc. holds FDA 510(k) medical device clearances, first cleared 1997, most recent 2025, with 90 FDA device recalls on record.
Clearances by Ortho-Clinical Diagnostics, Inc. — page 2
101–106 of 106- K983031 — VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY
- K984011 — VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL RANGE VERIFIERS
- K983507 — VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY
- K983513 — VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
- K982649 — VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III
- K973331 — VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)
Data sourced from openFDA. This site is unofficial and independent of the FDA.