Chrysalis Intelligence · Sponsors · Gold Standard Diagnostics

Gold Standard Diagnostics

Davis, CA, US · 7 510(k) clearances

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals

Total clearances

7

2020-04-06 → 2025-10-10

Last 12 months

1

Product codes

2

Most recent

2025-10-10

Name variants in FDA filings: Gold Standard Diagnostics, LLC / Gold Standard Diagnostics

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
LSR	—	—	—	6	2021-03-22
GMQ	Antigens, Nontreponemal, All	Class II	Microbiology	1	2025-10-10

Filings

All 510(k) clearances (7)

Date	K-number	Device	Code	Class	Specialty
2025-10-10	K250249	Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System	GMQ	Class II	Microbiology
2021-03-22	K203296	Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit	LSR	—	—
2021-03-22	K203295	Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit	LSR	—	—
2021-03-22	K203292	Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit	LSR	—	—
2021-03-22	K203289	Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit	LSR	—	—
2020-04-06	K200025	Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit	LSR	—	—
2020-04-06	K200023	Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit	LSR	—	—