EUROIMMUN Anti-BP230-CF ELISA (IgG)— 510(k) K193115

Substantially Equivalent

Euroimmun Us, Inc.

FDA 510(k) clearance K193115 for EUROIMMUN Anti-BP230-CF ELISA (IgG), Substantially Equivalent on 2020-09-17. Applicant: Euroimmun Us, Inc..

Clearance details

Applicant: Euroimmun Us, Inc.
Product code: Code OEG
Advisory panel: Immunology
Date received: 2019-11-12
Decision date: 2020-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain Lakes, NJ, US

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