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.

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

BK230840- Elecsys Anti-CMV; PreciControl Anti-CMV; PreciControl Release Anti-CMV

510(k) Number: BK230840
Applicant: Roche Diagnostics
Device Name: Elecsys Anti-CMV; PreciControl Anti-CMV; PreciControl Release Anti-CMV
Decision Date: 11/3/2023

Supporting Documents

BK230840 Letter
BK230840 Summary

Top