Gold Standard Diagnostics Borrelia Burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit

Reagent, Borrelia Serological Reagent

Gold Standard Diagnostics

The following data is part of a premarket notification filed by Gold Standard Diagnostics with the FDA for Gold Standard Diagnostics Borrelia Burgdorferi Vlse-ospc Igg/igm Elisa Test Kit.

Pre-market Notification Details

Device IDK203289
510k NumberK203289
Device Name:Gold Standard Diagnostics Borrelia Burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit
ClassificationReagent, Borrelia Serological Reagent
Applicant Gold Standard Diagnostics 2851 Spafford St. Davis,  CA  95618
ContactNapoleon Monce
CorrespondentJennifer Roth
Gold Standard Diagnostics 2851 Spafford St. Davis,  CA  95618
Product CodeLSR  
CFR Regulation Number866.3830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-09
Decision Date2021-03-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B350GSD0110270 K203289 000

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