Euroimmun Us, Inc. - FDA 510(k) Cleared Devices
Recent clearances: EUROIMMUN Anti-BP230-CF ELISA (IgG), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG), EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern
19
Total
19
Cleared
0
Denied
FDA 510(k) Regulatory Record - Euroimmun Us, Inc. Immunology ✕
16 devices
Cleared
Sep 17, 2020
EUROIMMUN Anti-BP230-CF ELISA (IgG)
Immunology
310d
Cleared
Feb 28, 2019
EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue...
Immunology
91d
Cleared
May 24, 2018
EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS...
Immunology
269d
Cleared
Apr 20, 2018
EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern
Immunology
268d
Cleared
Apr 20, 2018
EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern
Immunology
268d
Cleared
Apr 17, 2015
EUROIMMUN IFA 40: HEP-20-10
Immunology
284d
Cleared
Jun 27, 2014
EUROIMMUN ANTI-PLA2R ELISA (IGG)
Immunology
347d
Cleared
Sep 13, 2010
EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST...
Immunology
252d
Cleared
Sep 02, 2010
EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)
Immunology
428d
Cleared
Sep 02, 2010
EUROIMMUN ANTI-M2-3E ELISA (IGG)
Immunology
363d
Cleared
Aug 07, 2009
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)
Immunology
297d
Cleared
Jul 28, 2009
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)
Immunology
287d