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510(k) K252627

Lyme-ID IgG Test; Bio-ID800 by Inanovate, Inc. — Product Code LSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2025
Date Received
August 20, 2025
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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