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05/18 9:33A (DJ) +HemaSure Files 510K With FDA For r/LS System >HMSR
Story 1672 (HMSR, SEPR, I/BTC, I/DRG, I/MTC, G/FDA, N/DJN, N/DJWI, N/RND...)
(MORE) DOW JONES NEWS 05-18-98
09:33 AM
Story 2030 HemaSure - 510K Filing -2: r/LS System Filters Blood >HMSR
MARLBOROUGH, Mass. (Dow Jones)--HemaSure Inc. (HMSR) filed a 510(k)
premarket notification application with the Food and Drug Administration for
its r/LS System.
In a press release Monday, the company said the r/LS system is designed to
increase the safety of donated blood by reducing leukocytes, or white blood
cells, in red blood cell concentrates.
HemaSure's 510(k) application for the r/LS System includes both human
clinical and laboratory data.
Leukocytes can cause adverse reactions in patients receiving blood
transfusions, such as fever, chills, immune system suppression and
immunological responses that can lead to patient rejection of subsequent blood
transfusions. Also, leukocytes can carry and transmit harmful viruses, such as
Hepatitis B and C, Epstein-Barr and CMV.
HemaSure develops and delivers filtration technologies for processing blood
components.
(END) DOW JONES NEWS 05-18-98
10:26 AM
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