Support: 888-992-3836
Copyright © 2023 InvestorsHub Inc.
Replies to post #151505 on Arrayit Corporation (ARYC)
MikeCr
07/01/19 12:06 PM
#151514 RE: rh22 #151505
A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR §807.92(a)(3)) that is not subject to premarket approval.
jhols001
07/01/19 12:09 PM
#151517 RE: rh22 #151505