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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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