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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 K172254
Device Name Lyme B. burgdorferi (IgM) MarStripe Test
Applicant
Trinity Biotech
60 Pineview Dr.
Buffalo,  NY  14031
Applicant Contact Kevin Lawson
Correspondent
Trinity Biotech
60 Pineview Dr.
Buffalo,  NY  14031
Correspondent Contact Kevin Lawson
Regulation Number866.3830
Classification Product Code
LSR  
Date Received07/26/2017
Decision Date 10/23/2017
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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