Medical Device Manufacturer · US , Morristown , NJ

Euroimmun Us, Inc. - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 2009
19
Total
19
Cleared
0
Denied

FDA 510(k) cleared devices by Euroimmun Us, Inc. Immunology

16 devices
1-16 of 16
Cleared Sep 17, 2020
EUROIMMUN Anti-BP230-CF ELISA (IgG)
K193115 · OEG
Immunology · 310d
Cleared Feb 28, 2019
EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue...
K183313 · MVM
Immunology · 91d
Cleared May 24, 2018
EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS...
K172582 · MOB
Immunology · 269d
Cleared Apr 20, 2018
EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern
K172244 · KTL
Immunology · 268d
Cleared Apr 20, 2018
EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern
K172252 · KTL
Immunology · 268d
Cleared Apr 17, 2015
EUROIMMUN IFA 40: HEP-20-10
K141827 · DHN
Immunology · 284d
Cleared Jun 27, 2014
EUROIMMUN ANTI-PLA2R ELISA (IGG)
K132195 · PGV
Immunology · 347d
Cleared Sep 13, 2010
EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST...
K100017 · OSK
Immunology · 252d
Cleared Sep 02, 2010
EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)
K091969 · NBO
Immunology · 428d
Cleared Sep 02, 2010
EUROIMMUN ANTI-M2-3E ELISA (IGG)
K092736 · DBM
Immunology · 363d
Cleared Aug 07, 2009
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)
K083053 · MST
Immunology · 297d
Cleared Jul 28, 2009
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)
K083052 · MST
Immunology · 287d
Cleared May 20, 2009
EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS
K083850 · MOB
Immunology · 147d
Cleared Apr 15, 2009
EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)
K083381 · LRM
Immunology · 152d
Cleared Apr 07, 2009
EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)
K082130 · MOB
Immunology · 252d
Cleared Mar 16, 2009
EUROIMMUN ANTI BP 180-4X ELISA (IGG)
K083615 · OEG
Immunology · 98d
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