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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Borrelia Serological Reagent
510(k) Number K252627
Device Name Lyme-ID IgG Test; Bio-ID800
Applicant
Inanovate, Inc.
4800 N. Career Ave. Suite 132
Sioux Falls,  SD  57107
Applicant Contact Aaron Harmon
Correspondent
Inanovate, Inc.
4800 N. Career Ave. Suite 132
Sioux Falls,  SD  57107
Correspondent Contact Aaron Harmon
Regulation Number866.3830
Classification Product Code
LSR  
Subsequent Product Code
NSU  
Date Received08/20/2025
Decision Date 11/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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