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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 K242872
Device Name iDart Lyme IgM ImmunoBlot Kit
Applicant
Id-Fish Technology, Inc.
556 Gibraltar Dr.
Milpitas,  CA  95035
Applicant Contact Jyotsna Shah
Correspondent
Id-Fish Technology, Inc.
556 Gibraltar Dr.
Milpitas,  CA  95035
Correspondent Contact Jyotsna Shah
Regulation Number866.3830
Classification Product Code
LSR  
Date Received09/23/2024
Decision Date 06/12/2025
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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