FDA Clears IVD Tests, Systems from Hamamatsu, Roche, Cepheid, Siemens Healthineers ...

The US FDA granted over a dozen 510(k) clearances in July to in vitro diagnostic products from Hamamatsu, Roche, Cepheid, Siemens Healthineers, and others, covering digital pathology systems, clinical chemistry tests, immunoassays, antimicrobial susceptibility tests, and molecular assays.

This Wire brief sits within Fusion42's coverage of Diagnostics.