Haemonetics platelet kits' 510(k) status to be discussed with FDA following warning letter.
This article was originally published in The Gray Sheet
Executive Summary
HAEMONETICS PLATELET COLLECTION KITS' PREMARKET STATUS TO BE DISCUSSED WITH FDA at an upcoming meeting, the company says. Haemonetics is currently gathering data to convince the agency that it erred in stating in a Nov. 17 warning letter that two of the company's currently marketed platelet collection filtration kits require 510(k) clearance.