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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 K200023
Device Name Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
Applicant
Gold Standard Diagnostics
2851 Spafford St.
Davis,  CA  95618
Applicant Contact Napoleon Monce
Correspondent
Gold Standard Diagnostics
2851 Spafford St.
Davis,  CA  95618
Correspondent Contact Napoleon Monce
Regulation Number866.3830
Classification Product Code
LSR  
Date Received01/06/2020
Decision Date 04/06/2020
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
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