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510(k) K230863

ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit by Zeus Scientific — Product Code LSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2023
Date Received
March 29, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Borrelia Serological Reagent
Device Class
Class II
Regulation Number
866.3830
Review Panel
MI
Submission Type

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