Decision Diagnostics Corp (DECN)

[Hopefull17]

EUA - Emergency Use Authorization - FDA Website - Lists current EUA's - Does NOT show Application Status - DECN is NOT Authorized as of this post - Roche is listed and a copy of the Letter informing of the EUA is available for review.

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

There is a page entitled, "How to Submit a Pre-EUA for In vitro Diagnostics to FDA … Pre-EUA information for manufacturers of IVD tests"

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/how-submit-pre-eua-vitro-diagnostics-fda