K191240

Substantially Equivalent

ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System

Applicant: Zeus Scientific, Inc.
Product code: LSR
Advisory panel: Microbiology
Date received: 2019-05-08
Decision date: 2019-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raritan, NJ, US

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