Lifestream seeks to clear rapid cholesterol test:
This article was originally published in Clinica
Executive Summary
Lifestream Technologies has filed a 510(k) premarket notification with the FDA for its hand-held cholesterol test, Cholestron PRO II. The total whole-blood cholesterol test takes three minutes to perform and can be carried out in a doctor's office. The company forecast that the entire system would cost about $350, while each test would cost about three dollars. "Due to our exceptionally favourable clinical results, we foresee no major delays in the acceptance process," said Christopher Maus, the company's president.