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510(k) K193051

LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set by DiaSorin, Inc. — Product Code LSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2020
Date Received
November 1, 2019
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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