CMTR-CHEMTRAK FDA OK Message Board

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Biotech / Medical : CMTR-CHEMTRAK FDA OK

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To: surfinSteve who wrote (450)	3/5/1997 11:17:00 AM
From: DeadHead	of 1172

I don't want to get into a flame war here. Let's just agree to disagree on standards of behavior and focus on what we have in common: sharing information about Chemtrak. Agreed? On the topic of CMTR, anyone know when the 510(K) request was submitted to the FDA? It seems a bit odd that they had to wait over a year just to receive the right to say they have a "highly accurate" HP test. I wonder how long it would take for them to receive a CLIA waiver as opposed to clearance to market the test to home users? From Astra-Merck's perspective, I'm sure they would benefit from a CLIA waiver while waiting for the green light on home use (which would obviously leap-frog the benefits of the CLIA waiver).

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