An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

In this section: Substantially Equivalent 510(k) Device Information

BK200549 - ORTHO Optix Reader

510(k) Number: BK200549
Applicant: Ortho-Clinical Diagnostics, Inc.
Device Name: ORTHO Optix™ Reader
Decision Date: 3/10/2021

Supporting Documents

BK200549 Letter
BK200549 Summary

Top