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