510(k) K161513— Anti-Borrelia burgdorferi US Westernblot (IgG)

Substantially Equivalent

Euroimmun US

Clearance details

Applicant: Euroimmun US
Product code: Code LSR
Advisory panel: Microbiology
Date received: 2016-06-02
Decision date: 2016-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morris Plains, NJ, US

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