Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1373794636
Device Listing 1373794636
Listing Summary
#
Listing key
1373794636
Premarket submission
K180264
Device
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
Applicant
Gold Standard Diagnostics
Product code
LSR
Decision date
2018-05-02
Related Registrations
#
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