510(k)
BioMérieux Submits Dual FDA Marketing, CLIA Waiver Application for Respiratory, Sore Throat Panel
The French diagnostics maker is seeking both 510(k) clearance and a CLIA waiver for the multiplex PCR test, which can be used at the point of care.
T2 Biosystems Gets FDA 510(k) Clearance for Biothreat Panel
The clearance allows the firm to immediately begin marketing an assay that simultaneously detects six biothreat pathogens directly from blood.
Abbott, Beckman Coulter, Thermo Fisher Scientific, Others Gain FDA Clearances in August
The clearances granted in August include hematology equipment, COVID-19 tests, a lupus test, and reagent packs to aid management of cancer patients.
FDA Releases Draft Guidance for 510(k) Clearances
In three draft documents, agency officials lay out the types of predicate devices and evidence they expect from device developers seeking marketing clearance.
Top Five Articles on 360Dx Last Week: Prison for Lab Owner; Grail's Cancer Detection Deal; More
Last week, readers were most interested in a 27-year prison term handed down for a $463 million scheme to defraud Medicare.