FDA 510(k) Applications Submitted by Euroimmun US, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K172244 07/26/2017 EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern Euroimmun US, Inc.
K172252 07/26/2017 EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern Euroimmun US, Inc.
K183313 11/29/2018 EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) Euroimmun US, Inc.
K193115 11/12/2019 EUROIMMUN Anti-BP230-CF ELISA (IgG) Euroimmun US, Inc.
K153303 11/16/2015 EUROIMMUN Anti-West Nile Virus ELISA (IgG) EUROIMMUN US, INC.
K153308 11/17/2015 EUROIMMUN Anti-West Nile Virus ELISA (IgM) EUROIMMUN US, INC.
K172582 08/28/2017 EUROIMMUN IFA Granulocyte MosaicÖ EUROPattern and EUROIMMUN EUROPLUS Granulocyte MosaicÖ EUROPattern Euroimmun US, Inc.
K172722 09/11/2017 Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) EUROIMMUN US, Inc.


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