Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) is one of 26109 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) - FDA 510(k) Cleared D...
Recent clearances: Sofia Influenza A+B FIA, Sofia 2 SARS Antigen+ FIA, Sofia Lyme FIA
3
Total
3
Cleared
0
Denied
Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) has 3 FDA 510(k) cleared medical devices. Based in San Diego, US.
Latest FDA clearance: Sep 2026. Active since 2026. Primary specialty: Microbiology.
Browse the FDA 510(k) cleared devices submitted by Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Ortho Clinical Diagnostics Inc. (QuidelOrtho) as regulatory consultant.
FDA 510(k) Regulatory Record - Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)
3 devices