510(k)
Siemens Healthineers, Roche, Beckman Coulter, Abbott Gain FDA 510(k) Clearances in December
The agency cleared tests to help predict cardiovascular disease, rule out causes of Alzheimer's disease, provide early pregnancy detection, and identify prior drug use, among other uses.
Precision BioLogic Nabs FDA 510(k) Clearance for Factor IX Deficiency
The firm said its Cryocheck Chromogenic Factor IX test for managing hemophilia B is the only FDA-cleared chromogenic FIX assay on the US market.
Accelerate Diagnostics Seeks FDA 510(k) Clearance for Expanded Abx Susceptibility Tests
The firm hopes to secure clearance to update its antibiotic susceptibility testing menu, susceptibility breakpoints, and de-escalation options to aid patient discharge.
Roche Alzheimer's Disease Assays Obtain FDA 510(k) Clearance
The two cerebrospinal fluid-based Elecsys tests will be available on Roche's Cobas immunoassay analyzers.
DiaSorin, PerkinElmer, Roche, Others Nab FDA 510(k) Clearances in November
This month's clearances include assays for congenital cytomegalovirus infection, hepatitis C infections, genetic diseases in newborns, and hemostasis measurements.