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

Euroimmun Us, Inc. has 19 FDA 510(k) cleared immunology devices. Based in Morristown, US.

Historical record: 19 cleared submissions from 2009 to 2020.

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) cleared devices by Euroimmun Us, Inc.

19 devices
1-19 of 19
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 Dec 10, 2017
Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)
K172722 · LSR
Microbiology · 90d
Cleared Aug 12, 2016
EUROIMMUN Anti-West Nile Virus ELISA (IgM)
K153308 · NOP
Microbiology · 269d
Cleared Aug 10, 2016
EUROIMMUN Anti-West Nile Virus ELISA (IgG)
K153303 · NOP
Microbiology · 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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