Euroimmun US - FDA 510(k) Cleared Devices
12
Total
11
Cleared
1
Denied
9 devices
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 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