510(k) K230863— ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit

Substantially Equivalent

Zeus Scientific

Clearance details

Applicant: Zeus Scientific
Product code: Code LSR
Advisory panel: Microbiology
Date received: 2023-03-29
Decision date: 2023-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.