Spectral Receives Registration Notification for Assays in China

Spectral Diagnostics announced that it has received formal approval of registration by China's State Food and Drug Administration (SFDA) for Spectral's rapid cardiac marker series of assays, the Decision Point product line. The SFDA is the state authority in China governing all drug and medical devices manufactured by both domestic and foreign companies. The SFDA registration process has taken almost two years to complete and has required the presentation of significant clinical data, review of Spectral's FDA and Health Canada submissions, as well as Spectral's quality programs in manufacturing and technical service.

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