In Brief: Venisect
This article was originally published in The Gray Sheet
Executive Summary
Venisect: Firm's Laser Lancet 510(k) requires additional information, FDA tells firm. LaBarge, Inc., which holds exclusive manufacturing rights to the laser device used for taking blood samples, says "Venisect intends to respond expeditiously," although clearance "could possibly be delayed several months." The request for additional information is the third FDA has made since submission of the 510(k) in December 1995 ("The Gray Sheet" Feb. 5, I&W-6)...