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Biotech / Medical : ACMI - Accumed Inc. -- Ignore unavailable to you. Want to Upgrade?


To: Sigmund who wrote (938)1/5/1998 6:30:00 PM
From: Dana Winrow  Respond to of 1894
 
Sigmund has asked about predicate devices:

I am assuming that this goes back to the discussion about the AccuZone, and, while I do not know the particulars about the FDA submission for this product (i.e., which products will be listed as predicate devices), I do know that there are other automated Kirby-Bauer readers currently on the market. I know of a product called "BIOMIC", manufactured by Giles Scientific in NYC; I believe there are others.

FYI: The AccuZone costs about one-half the price and is capable of reading more types of plates and identifying susceptibility of more kinds of antibiotics than these other readers.

Dana Winrow
Director, Investor Relations
AccuMed International, Inc.