K-number	K252627
Device name	Lyme-ID IgG Test; Bio-ID800
Applicant	Inanovate, Inc.
Product code	LSR
Device class	Class II
Decision date	Nov 14, 2025
Decision	Substantially Equivalent
Regulation	866.3830

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Lyme-ID IgG Test; Bio-ID800

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