FDA 510(k) Applications Submitted by ORTHO CLINICAL DIAGNOSTICS

FDA 510(k) Number Submission Date Device Name Applicant
K200236 01/30/2020 VITROS BRAHMS PCT Reagent Pack and Calibrators Ortho Clinical Diagnostics
K142595 09/15/2014 VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II ORTHO CLINICAL DIAGNOSTICS
K171168 04/21/2017 VITROS Immunodiagnostic Products Insulin Calibrators Ortho Clinical Diagnostics
K163433 12/07/2016 VITROS Chemistry Products GLU Slides Ortho Clinical Diagnostics
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
K212648 08/23/2021 VITROS Immunodiagnostic Products CK-MB Reagent Pack Ortho Clinical Diagnostics
K213626 11/17/2021 VITROS AFP Ortho Clinical Diagnostics
K152433 08/27/2015 VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 ORTHO CLINICAL DIAGNOSTICS
K201312 05/18/2020 VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack Ortho Clinical Diagnostics
K160712 03/15/2016 VITROS Chemistry Products hsCRP Reagent Ortho Clinical Diagnostics
K162020 07/21/2016 VITROS Chemistry Products Cl- Slides Ortho Clinical Diagnostics
K221355 05/10/2022 VITROS Immuodiagnostic Products CA 125 II Reagent Pack Ortho Clinical Diagnostics
K231517 05/25/2023 VITROS Immunodiagnostic Products CEA Reagent Pack Ortho Clinical Diagnostics


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact