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Gold Standard Diagnostics

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories1
Latest Approval2021-03-22
TypeNumberDevice NameCodeDate
510(k) K203296 Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit LSR 2021-03-22 View
510(k) K203292 Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit LSR 2021-03-22 View
510(k) K203289 Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit LSR 2021-03-22 View
510(k) K203295 Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit LSR 2021-03-22 View
510(k) K200025 Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit LSR 2020-04-06 View
510(k) K200023 Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit LSR 2020-04-06 View
510(k) K180264 Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit LSR 2018-05-02 View
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