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510(k) K161513

Anti-Borrelia burgdorferi US Westernblot (IgG) by Euroimmun US — Product Code LSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2016
Date Received
June 2, 2016
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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