I am doing some work with a small toxicology group that is using the Olympus Au640e. Being in Sandy Pearson's CMS/CLIA district (District 6, Texas Region), I want to be sure they have the proper documentation for the system to be considered moderate complexity. Unfortunately, the CLIA FDA cross check website does not list anything toxicology related as approved on the Au640e. Has anyone in this group been able to locate anything related to the Au640 and Au640e being "substantially equivalent" in the eyes of the FDA?
Thank you,
Marc
