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

To: Ryan Weisman who wrote (743)	12/20/1997 12:58:00 AM
From: Sigmund	Respond to of 1894

Good to hear that Dr. Winrow will monitor this thread and respond when appropriate. I have a question. What is this 510(k) process and why does it work so quickly? How does the AccuZone device differ from say NeoPath's AutoPap re the requirements for FDA approval? Are the approval requirements the same? Is it the case that there just is no doubters about the safety of applying automation? I would like to understand this better. It sounds like no regulatory approval is required Internationally .....why is this the case? This AccuZone reader sounds like a real winner commercially so the timing of approval is very important.

To: Ryan Weisman who wrote (743)	12/20/1997 4:46:00 PM
From: Frank Buck	Read Replies (3) \| Respond to of 1894

Happy Holidays