IMI International's Cholesterol 1,2,3
This article was originally published in The Gray Sheet
Executive SummaryRapid, non-invasive skin cholesterol test will be launched in Canada by the end of the year, following receipt of a medical device license by Health Canada, firm announces Jan. 29. Three-minute test uses a hand-held spectrophotometer to determine color change in a drop of liquid held in the palm of the hand. Toronto firm will submit a 510(k) application to FDA in the next several months and is negotiating with potential distributors to doctors' offices, pharmacies, clinics and laboratories. A home version of the test will probably be available in 2003
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