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510(k) K203289

Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit by Gold Standard Diagnostics — Product Code LSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2021
Date Received
November 9, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Borrelia Serological Reagent
Device Class
Class II
Regulation Number
866.3830
Review Panel
MI
Submission Type

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