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Posted On: 07/27/2021 9:45:22 PM
Post# of 22461
Re: Puravida19 #20451
This is a load of crap. There are many companies both public and private that will assist in steering new companies and applicants through the 510K application process. I list a link for review of just one of many.
Quote:
Why hasn't the FDA approved the Innova test kit for use in the U.S.?
IMO, Innova did not understand the intricacies of FDA approvals
Quote:
https://www.fdahelp.us/510k-fda-submission.html
Sunny
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