The US Food and Drug Administration’s effort to transition products cleared through Emergency Use Authorizations to traditional regulatory pathways hit another milestone on 9 November as ACON Laboratories’ Flowflex became the first COVID-19 antigen home test to receive a 510(k) clearance.
In addition to being the first test cleared via 510(k), Flowflex is also the first antigen test and the first indicated for use in children under 18. The first COVID-19...
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