Gold Standard Diagnostics is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
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
Gold Standard Diagnostics has 14 FDA 510(k) cleared microbiology devices. Based in Davis, US.
Last cleared in 2021. Active since 2012.
Browse the complete list of FDA 510(k) cleared microbiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Gold Standard Diagnostics
14 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
Jan 28, 2014
GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT
Immunology
265d
Cleared
Jun 01, 2012
BORRELIA BURGDORFERI IGM BLOT TEST
Microbiology
155d
Cleared
Apr 11, 2012
BORRELIA BURGDORFERI IGG BLOT TEST
Microbiology
104d