FDA 510(k) Applications Submitted by DECLAN HYNES

FDA 510(k) Number Submission Date Device Name Applicant
K221197 04/25/2022 VITROS Immunodiagnostic Products Intact PTH II Reagent Pack Ortho Clinical Diagnostics
K231525 05/26/2023 VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack Ortho Clinical Diagnostics
K101921 07/09/2010 VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT ORTHO-CLINICAL DIAGNOSTICS
K212648 08/23/2021 VITROS Immunodiagnostic Products CK-MB Reagent Pack Ortho Clinical Diagnostics
K213626 11/17/2021 VITROS AFP Ortho Clinical Diagnostics


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