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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 K230863
Device Name ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit
Applicant
ZEUS Scientific
200 Evans Way
Branchburg,  NJ  08876
Applicant Contact Mark Kopnitsky
Correspondent
ZEUS Scientific
200 Evans Way
Branchburg,  NJ  08876
Correspondent Contact Mark Kopnitsky
Regulation Number866.3830
Classification Product Code
LSR  
Subsequent Product Code
QCH  
Date Received03/29/2023
Decision Date 07/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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