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510(k) K173496

Sofia 2 Lyme FIA, Sofia Lyme Control Set by Quidel Corporation — Product Code LSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2018
Date Received
November 13, 2017
Clearance Type
Dual Track
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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