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

Substantially Equivalent

Euroimmun US

FDA 510(k) clearance K142038 for EUROIMMUN LYME ELISA(IgG/IgM), Substantially Equivalent on 2015-05-04. Applicant: Euroimmun US. Device class: 2.

Clearance details

Applicant: Euroimmun US
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 2014-07-28
Decision date: 2015-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morris Plains, NJ, US

Download summary PDF View on FDA.gov ↗

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