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