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

BK210600 - NEO Iris

510(k) Number: BK210600
Applicant: Immucor, Inc.
Device Name: NEO Iris
Decision Date: 9/3/2021

Supporting Documents

BK210600 Letter
BK210600 Summary

Top