Cleared Traditional

ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit

K230863 · Zeus Scientific · Microbiology
Jul 2023
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K230863 is an FDA 510(k) clearance for the ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit, a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR), submitted by Zeus Scientific (Branchburg, US). The FDA issued a Cleared decision on July 13, 2023, 106 days after receiving the submission on March 29, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K230863 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 2023
Decision Date July 13, 2023
Days to Decision 106 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LSR — Reagent, Borrelia Serological Reagent
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3830

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