510(k)
Siemens Healthineers, Roche Diagnostics, Thermo Fisher Scientific, Others Nab FDA Clearances in July
Siemens Healthineers obtained clearances for four tests, including its N Latex FLC kappa and lambda reagents to diagnose multiple myeloma and other medical conditions.
NYU Langone Health Gets FDA Clearance for Solid Tumor Gene Sequencing Test
The test uses next-generation sequencing to detect cancer-linked mutations in 607 genes to help guide patient treatment.
FDA Clears Inova Diagnostics Digital Multianalyte System, Celiac Test
The system uses particle-based multianalyte technology that allows it to deliver up to 720 results per hour using a 12-analyte test cartridge.
FDA Clears Sysmex Hematology Analyzer With Blood Bank Mode
The firm said that its XN Blood Bank mode provides accurate cell counts on products that are important to blood centers and blood banks.
Immunodiagnostic Systems, Retractable Technologies, Immunalysis Receive FDA 510(k) Clearances in April
Immunalysis received 510(k) clearance for its Sefria PCP Oral Fluid Enzyme Immunoassay for the analysis of phenylcyclohexyl piperidine, or PCP, in human oral fluid.