FDA 510(k) Applications Submitted by EUROIMMUN US

FDA 510(k) Number Submission Date Device Name Applicant
K112221 08/02/2011 EUROIMMUN ANTI-SLA/LP ELISA(LGG) EUROIMMUN US
K112223 08/02/2011 EUROIMMUN ANTI-LKM-1 ELISA(LGG) EUROIMMUN US
K112996 10/07/2011 EUROIMMUN ANTI-ENA POOL ELISA (IGG) EUROIMMUN US
K123261 10/18/2012 EUROIMMUN ANTI-NRNP/SM ELISA (IGG) EUROIMMUN US
K113439 11/21/2011 EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG) EUROIMMUN US
K123660 11/28/2012 25-OH VITAMIN D ELISA EUROIMMUN US
K140224 01/29/2014 EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) EUROIMMUN US
DEN140002 03/28/2014 EUROIMMUN ANTI-PLA2R IFA EUROIMMUN US
K131185 04/26/2013 ANA SCREEN ELISA (IGG) EUROIMMUN US
K161513 06/02/2016 Anti-Borrelia burgdorferi US Westernblot (IgG) EUROIMMUN US
K131791 06/18/2013 IFA 40: HEP-20-10 EUROIMMUN US
K142038 07/28/2014 EUROIMMUN LYME ELISA(IgG/IgM) EUROIMMUN US


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