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510(k) K180264

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2018
Date Received
January 30, 2018
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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