FDA 510(k) Applications Submitted by Rebecca Lewis

FDA 510(k) Number Submission Date Device Name Applicant
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
K241534 05/30/2024 VITROS Immunodiagnostic Products Syphilis Reagent Pack Ortho Clinical Diagnostics
K233581 11/07/2023 VITROS Immunodiagnostic Products Total ▀-hCG II Reagent Pack Ortho Clinical Diagnostics


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