Euroimmun US is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Euroimmun US - FDA 510(k) Cleared Devices
12
Total
11
Cleared
1
Denied
Euroimmun US has 11 FDA 510(k) cleared immunology devices. Based in Morris Plains, US.
Historical record: 11 cleared submissions from 2012 to 2016.
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
12 devices
Cleared
Aug 25, 2016
Anti-Borrelia burgdorferi US Westernblot (IgG)
Microbiology
84d
Cleared
May 04, 2015
EUROIMMUN LYME ELISA(IgG/IgM)
Microbiology
280d
Cleared
Dec 09, 2014
EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)
Immunology
314d
Not Cleared
May 29, 2014
EUROIMMUN ANTI-PLA2R IFA
Immunology
62d
Cleared
Feb 26, 2014
IFA 40: HEP-20-10
Immunology
253d
Cleared
Jul 17, 2013
25-OH VITAMIN D ELISA
Chemistry
231d
Cleared
Jul 15, 2013
ANA SCREEN ELISA (IGG)
Immunology
80d
Cleared
Jun 12, 2013
EUROIMMUN ANTI-NRNP/SM ELISA (IGG)
Immunology
237d
Cleared
Apr 12, 2013
EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)
Immunology
508d
Cleared
Apr 09, 2013
EUROIMMUN ANTI-ENA POOL ELISA (IGG)
Immunology
550d
Cleared
Sep 11, 2012
EUROIMMUN ANTI-SLA/LP ELISA(LGG)
Immunology
406d
Cleared
Sep 11, 2012
EUROIMMUN ANTI-LKM-1 ELISA(LGG)
Immunology
406d