AroCell announced today that the US Food and Drug Administration (FDA) has resumes AroCells 510(k) submission after the impact of relocation due to the COVID-19 pandemic.
Due to the sustained volume of EUA (Emergency Use Authorization) requests and the continued importance of testing in the response to the pandemic, FDA delayed all the submission reviews, which now are resumed.
“We are excited about this news. This is an important step for future commercial success in US for AroCell. Clearance of the 510(k) for AroCell TK 210 ELISA will make the product available for clinical testing of patient samples and is an important step for market penetration in US”, says Anders Hultman, CEO of AroCell.