Heparin analyzer downclassification
This article was originally published in The Gray Sheet
Executive Summary
FDA finalizes reclassification of automated heparin analyzers from Class III to Class II in an Oct. 5 Federal Register notice. The downclassification was based on information contained in a reclassification petition submitted by HemoTech. FDA had proposed the downclassification in September 1992 ("The Gray Sheet" Sept. 21, 1992, p. 23).