Medical Device Manufacturer · US , Morristown , NJ

Euroimmun Us, Inc.

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

Euroimmun Us, Inc. — FDA 510(k) Submissions

Euroimmun Us, Inc. has submitted 19 FDA 510(k) premarket notifications since 2009, of which 19 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Test System, Antineutrophil Cytoplasmic Antibodies (anca), Elisa, Antibody, West Nile Virus, Anti-dna Indirect Immunofluorescent Solid Phase, Antibodies, Gliadin, Autoantibodies, Skin (bullous Pemphigoid 180 And Bullous Pemphigoid 230 . Use the specialty filter in the sidebar to narrow results.

19 devices
1–19 of 19
EUROIMMUN Anti-BP230-CF ELISA (IgG)
K193115 · OEG Autoantibodies, Skin... · Immunology
Sep 2020 310d
EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)
K183313 · MVM Autoantibodies,... · Immunology
Feb 2019 91d
EUROIMMUN IFA Granulocyte Mosaic? EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic? EUROPattern
K172582 · MOB Test System,... · Immunology
May 2018 269d
EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern
K172244 · KTL Anti-dna Indirect... · Immunology
Apr 2018 268d
EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern
K172252 · KTL Anti-dna Indirect... · Immunology
Apr 2018 268d
Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)
K172722 · LSR Reagent, Borrelia... · Microbiology
Dec 2017 90d
EUROIMMUN Anti-West Nile Virus ELISA (IgM)
K153308 · NOP Elisa, Antibody, West... · Microbiology
Aug 2016 269d
EUROIMMUN Anti-West Nile Virus ELISA (IgG)
K153303 · NOP Elisa, Antibody, West... · Microbiology
Aug 2016 268d
EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE
K141827 · DHN Antinuclear Antibody,... · Immunology
Apr 2015 284d
EUROIMMUN ANTI-PLA2R ELISA (IGG)
K132195 · PGV Anti-phospholipase A2... · Immunology
Jun 2014 347d
EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM
K100017 · OSK Anti-glutamate Receptor... · Immunology
Sep 2010 252d
EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)
K091969 · NBO Autoantibodies, Skin... · Immunology
Sep 2010 428d
EUROIMMUN ANTI-M2-3E ELISA (IGG)
K092736 · DBM Antimitochondrial... · Immunology
Sep 2010 363d
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)
K083053 · MST Antibodies, Gliadin · Immunology
Aug 2009 297d
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)
K083052 · MST Antibodies, Gliadin · Immunology
Jul 2009 287d
EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS
K083850 · MOB Test System,... · Immunology
May 2009 147d
EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)
K083381 · LRM Anti-dna Antibody... · Immunology
Apr 2009 152d
EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)
K082130 · MOB Test System,... · Immunology
Apr 2009 252d
EUROIMMUN ANTI BP 180-4X ELISA (IGG)
K083615 · OEG Autoantibodies, Skin... · Immunology
Mar 2009 98d
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