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510(k) K252627

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

K252627 is an FDA 510(k) premarket notification submitted by Inanovate, Inc. for the device "Lyme-ID IgG Test; Bio-ID800". The FDA issued a decision of Substantially Equivalent on November 14, 2025. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830.

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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FDA data resources