Interesting. So GenUltimate is genstrip. The FDA approval referred to by pluto here was Shasta's originally not DECN's, but was subsequently acquired by DECN.
So thus far, there is ZERO evidence of DECN (or one of their subsidiaries!) successfully navigating their own diagnostic product through any FDA approval or exemption process?
The mystery is Genaccord! RelyMX which is supposed to be FDA cleared according to the Pharmatech website. but whoever 'cleared' this was not DECN, Pharmatech, nor The Bio Co. The 510K submission number will be on the box, so we will see whose strips DECN are now rebadging and selling there, if/when this info becomes available.!