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Biotech / Medical : BICO & VITK

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To: Money Maker (MM) who wrote (1804)	7/9/1998 9:37:00 AM
From: TJG	Read Replies (1) of 2395

MM ..excellent post...Your calculations show the potential of BICO is greater then ever imagined...IMO, The limitation of the Diasensor 1000 unit is only it's reliability, certainly not the potential market. On that note I have been looking into the CE mark process and what it takes to gain the CE mark approval. After what I have read a medical device needs to jump through numerous and difficult "hoops" to get a CE mark. I have sent an E-mail to BICO asking for the test files that they have on the 1000 which gave it the final CE mark approval. I will post any info that I get on this issue in the future. However, (IMHO), I feel that the unit must have preformed well to get the CE mark in the first place... TJG

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