Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)— 510(k) K172722

Substantially Equivalent

Euroimmun Us, Inc.

FDA 510(k) clearance K172722 for Anti-Borrelia burgdorferi US EUROLINE-WB (IgM), Substantially Equivalent on 2017-12-10. Applicant: Euroimmun Us, Inc..

Clearance details

Applicant: Euroimmun Us, Inc.
Product code: Code LSR
Advisory panel: Microbiology
Date received: 2017-09-11
Decision date: 2017-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain Lakes, NJ, US

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