Euroimmun Us, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
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
Euroimmun Us, Inc. has 19 FDA 510(k) cleared immunology devices. Based in Morristown, US.
Historical record: 19 cleared submissions from 2009 to 2020.
Browse the complete list of FDA 510(k) cleared immunology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Euroimmun Us, Inc.
19 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
Dec 10, 2017
Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)
Microbiology
90d
Cleared
Aug 12, 2016
EUROIMMUN Anti-West Nile Virus ELISA (IgM)
Microbiology
269d
Cleared
Aug 10, 2016
EUROIMMUN Anti-West Nile Virus ELISA (IgG)
Microbiology
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