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Re: None

Thursday, 05/21/2020 5:02:06 PM

Thursday, May 21, 2020 5:02:06 PM

Post# of 97078
From the April 7th PR

DECN received the Pre-EUA Acknowledgement and device serial number on Saturday, April 4, 2020. Later on this same day FDA counsel had several exchanges with FDA EUA staff. In one of those exchanges, the FDA provided Guidance for our final product testing.




Looking over the GenVIro documents from today, at the top of a document it has the solution for the connection problem they were experiencing, I wonder if this was the issue the FDA was having while testing and guidance was given to fix this issue.