Attana completes FDA Medical Device Class 1 listing and facility registration
Attana is pleased to announce today that it has completed a Medical Device listing of Attana Cell™ 250 and a facility registration of Attana, with the U.S. Food and Drug Administration (FDA).The facility registration and listing of Attana Cell™ 250 as a Class I device (510(k) exempt) are the first regulatory requirements for marketing Attana’s instruments towards the clinical diagnostics market. In 2021, Attana intends to complement these by filing for an FDA approval of at least one complementary assay as a Class II device, subject to 510(k) clearance. Simultaneous to these efforts, Attana
