Centers For Disease Control and Prevention - FDA 510(k) Cleared Devic...

Centers For Disease Control and Prevention is the United States federal public health agency under the Department of Health and Human Services. Headquartered in Atlanta, Georgia, the CDC protects public health through disease control and prevention domestically and worldwide.

The CDC has received 25 FDA 510(k) clearances from 29 total submissions since 1981. The agency's regulatory portfolio is dominated by Microbiology devices, representing 97% of submissions. Latest clearance activity in 2025 demonstrates continued engagement in FDA regulatory pathways.

The CDC's cleared devices focus on infectious disease diagnostics and detection. Recent clearances include real-time PCR assays and primer-probe sets for pathogens such as influenza, orthopoxvirus, Bacillus anthracis, and Francisella tularensis. These tools support the agency's core mission of rapid disease identification and outbreak response.

Explore the complete regulatory record, including specific device names, product codes, and clearance dates in the database.