510(k)

Werfen Gets FDA Clearance for Thromboelastometry System

CDC, Abbott, Roche, BioMérieux Get FDA 510(k) Clearances in June

Becton Dickinson High-Throughput MDx Module, Triplex STI Test Get FDA 510(k)Clearance

Biomerica Submits H. Pylori Test to FDA

FDA Clears Inspirata Dynamyx Digital Pathology Software

23andMe Gains FDA Clearance for Direct-to-Consumer Prostate Cancer Genetic Risk Test

Werfen POC Hemostasis System Obtains FDA 510(k) Clearance

Ortho Clinical Diagnostics, Siemens Healthineers, Roche, and Others Obtain FDA Clearances in October

Clever Culture Systems Nabs FDA Clearance for Culture Screening Instrument With MRSA Samples

OpGen Receives FDA Clearance for AMR Panel, Prelim Q3 Revenues Up 9 Percent

Siemens Healthineers, Roche Diagnostics, Thermo Fisher Scientific, Others Nab FDA Clearances in July

NYU Langone Health Gets FDA Clearance for Solid Tumor Gene Sequencing Test

FDA Clears Inova Diagnostics Digital Multianalyte System, Celiac Test

FDA Clears Sysmex Hematology Analyzer With Blood Bank Mode

Immunodiagnostic Systems, Retractable Technologies, Immunalysis Receive FDA 510(k) Clearances in April

Gold Standard Diagnostics Nabs FDA Clearance for Lyme Disease Test

FDA Clears Zymo Research Coronavirus Sample Collection Device

DiaSorin, Roche, Inova Diagnostics Receive FDA 510(k) Clearances in February

Inova Diagnostics IgG Antibody Determination Kit for Lupus Nabs FDA Clearance

Luminex Nabs $11.3M From BARDA to Develop Test for SARS-CoV-2, Flu, RSV