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

BK210625 - IH-500

510(k) Number: BK210625
Applicant: Bio-Rad Medical Diagnostics GmbH
Device Name: IH-500
Decision Date: 2/28/2022

Supporting Documents

BK210625 Letter
BK210625 Summary

Top