Whatman gets 510(k) for newborn specimen filter:
This article was originally published in Clinica
Executive Summary
UK filter specialist Whatman International has received US marketing clearance for its newborn screening specimen collection paper, BFC 180. Whatman is selling the filter paper in custom-printed formats or as a bulk product for OEM customers. US 510(k) clearance involved validation with the 12 most common blood analytes tested in the US Newborn Screening Program.