This is a load of crap. There are many companie
Post# of 22453
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