Arrayit Corporation (ARYC)

[MikeCr]

If it's for the allergy test, there is no other multiplex allergy blood test FDA approved for the FDA to compare to. 510(K) needs a substantial equivalent test to compare to. The FDA may be requesting more data before approval.

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.