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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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