Gold Standard Diagnostics Borrelia Burgdorferi 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 Igm Elisa Test Kit.

Pre-market Notification Details

Device IDK200023
510k NumberK200023
Device Name:Gold Standard Diagnostics Borrelia Burgdorferi IgM ELISA Test Kit
ClassificationReagent, Borrelia Serological Reagent
Applicant Gold Standard Diagnostics 2851 Spafford St. Davis,  CA  95618
ContactNapoleon Monce
CorrespondentNapoleon Monce
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 Received2020-01-06
Decision Date2020-04-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B350GSD0110260 K200023 000

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