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Gold Standard Diagnostics

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K203295 Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitLSR2021-03-22 View
510(k) K203292 Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitLSR2021-03-22 View
510(k) K203289 Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test KitLSR2021-03-22 View
510(k) K203296 Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitLSR2021-03-22 View
510(k) K200025 Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitLSR2020-04-06 View
510(k) K200023 Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitLSR2020-04-06 View
510(k) K180264 Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitLSR2018-05-02 View
510(k) K113846 BORRELIA BURGDORFERI IGM BLOT TESTLSR2012-06-01 View
510(k) K113847 BORRELIA BURGDORFERI IGG BLOT TESTLSR2012-04-11 View
510(k) K110745 HELICOBACTER PYLORI ELISA IGG TEST KITLYR2012-03-02 View
510(k) K110899 GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KITLYR2012-02-01 View
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