510(k) K142038— EUROIMMUN LYME ELISA(IgG/IgM)

Substantially Equivalent

Euroimmun US

Clearance details

Applicant: Euroimmun US
Product code: Code LSR
Advisory panel: Microbiology
Date received: 2014-07-28
Decision date: 2015-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morris Plains, NJ, US

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