Sunquest Flexilab
This article was originally published in The Gray Sheet
Executive Summary
Blood bank and blood donor version 5.2 blood bank software module gains 510(k) clearance. The software is intended for use on the IBM AIX and the Compaq (DEC) Unix platforms. Sunquest will now resume marketing of the product. Sales of various versions began in 1982 but were suspended in early 1999 to comply with FDA regulations following a March 1994 determination by the agency that blood bank software was a medical device requiring premarket approval or 510(k) notification