Device Listing 1208849351

Listing Summary#

Listing key: 1208849351
Premarket submission: K203296
Device: Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
Applicant: Gold Standard Diagnostics
Product code: LSR
Decision date: 2021-03-22

Registration key, Registration, FEI table
Registration key	Registration	FEI	Company	Status	Initial importer	Expiration	Address
86821	3007208259	3007208259	GOLD STANDARD DIAGNOSTICS, LLC	1	Y	2026-01-01	2795 2nd St Ste 300 Davis CA US 95618