FDA 510(k) Applications Submitted by ZEUS Scientific Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K191240 05/08/2019 ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System ZEUS Scientific Inc.
K191398 05/24/2019 ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System ZEUS Scientific Inc.


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