1. Recommendations for dual 510(k) and CLIA waiver by application studies: guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, February 26, 2020 Subject(s): Clinical Laboratory TechniquesDevice ApprovalReagent Kits, DiagnosticUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
