Gold Standard Diagnostics - FDA 510(k) Cleared Devices
Recent clearances: Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit, Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit, Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gold Standard Diagnostics Microbiology ✕
13 devices
Cleared
Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit
Microbiology
133d
Cleared
Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
Microbiology
133d
Cleared
Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
Microbiology
133d
Cleared
Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
Microbiology
133d
Cleared
Apr 06, 2020
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
Microbiology
91d
Cleared
Apr 06, 2020
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
Microbiology
91d
Cleared
May 02, 2018
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
Microbiology
92d
Cleared
Nov 12, 2015
Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test...
Microbiology
273d
Cleared
Feb 28, 2014
HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST
Microbiology
295d
Cleared
Jun 01, 2012
BORRELIA BURGDORFERI IGM BLOT TEST
Microbiology
155d
Cleared
Apr 11, 2012
BORRELIA BURGDORFERI IGG BLOT TEST
Microbiology
104d
Cleared
Mar 02, 2012
HELICOBACTER PYLORI ELISA IGG TEST KIT
Microbiology
351d