Co-Diagnostics submits FDA 510(k) application for Co-Dx PCR Pro platform

Co-Diagnostics announced that the Company has completed its first U.S. Food and Drug Administration application for 510(k) clearance for the Co-Dx PCR Pro instrument, and the Co-Dx PCR COVID-19 Test for over-the-counter use. Co-Diagnostics completed the submission via the FDA’s electronic Submissions Template And Resource system, and have received the acknowledgement from the FDA that the 510(k) application was received. eSTAR serves as a comprehensive resource for medical device manufacturers to standardize and consolidate the necessary information and links needed for 510(k) submission preparation.