ADOT - BIOMODA: Profitable Technology with Purpose Message Board

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Microcap & Penny Stocks : ADOT - BIOMODA: Profitable Technology with Purpose

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To: Mark Haythorn who wrote (461)	2/28/1998 2:46:00 PM
From: dexx	Read Replies (1) of 4650

Mark, you said: << An FDA approval is necessary- they would use something called a 510K submission. They are required to show that the test is effective, that they can adequately manufacture the test kit/device, and that they have acceptable marketing claims or labeling. >> A 510K is for getting approval on medical devices which are used in the body. This test uses a sputum sample. I see NO need for 510K approval. Efficacy tests are another matter. I will try to get in touch with the company to find out about that subject. Dexx

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