FDA 510(k) Applications Submitted by Gold Standard Diagnostics

FDA 510(k) Number	Submission Date	Device Name	Applicant
K131334	05/09/2013	HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST	GOLD STANDARD DIAGNOSTICS
K200023	01/06/2020	Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit	Gold Standard Diagnostics
K200025	01/06/2020	Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit	Gold Standard Diagnostics
K180264	01/30/2018	Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit	Gold Standard Diagnostics
K150358	02/12/2015	Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System	GOLD STANDARD DIAGNOSTICS
K110745	03/17/2011	HELICOBACTER PYLORI ELISA IGG TEST KIT	GOLD STANDARD DIAGNOSTICS
K110899	03/30/2011	GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT	GOLD STANDARD DIAGNOSTICS
K131330	05/08/2013	GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT	GOLD STANDARD DIAGNOSTICS
K203289	11/09/2020	Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit	Gold Standard Diagnostics
K203292	11/09/2020	Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit	Gold Standard Diagnostics
K203295	11/09/2020	Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit	Gold Standard Diagnostics
K203296	11/09/2020	Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit	Gold Standard Diagnostics
K113846	12/29/2011	BORRELIA BURGDORFERI IGM BLOT TEST	GOLD STANDARD DIAGNOSTICS
K113847	12/29/2011	BORRELIA BURGDORFERI IGG BLOT TEST	GOLD STANDARD DIAGNOSTICS