Company · US
Euroimmun Us, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2020. Name variants (Inc, Corp, punctuation) are merged.
37510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 5 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 3 |
| LSR | Reagent, Borrelia Serological Reagent | 3 |
| KTL | Anti-Dna Indirect Immunofluorescent Solid Phase | 2 |
| LKO | Anti-Rnp Antibody, Antigen And Control | 2 |
| MST | Antibodies, Gliadin | 2 |
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 2 |
| NIY | Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis | 2 |
| NOP | Elisa, Antibody, West Nile Virus | 2 |
| OEG | Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230 | 2 |
| PGV | Anti-Phospholipase A2 Receptor | 2 |
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 1 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 1 |
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 1 |
| MRG | System, Test, Vitamin D | 1 |
| MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 1 |
| NBO | Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3) | 1 |
| NBS | Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1) | 1 |
| NHX | Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 17, 2020 | K193115 | EUROIMMUN Anti-BP230-CF ELISA (IgG) Euroimmun Us, Inc. | OEG |
| Feb 28, 2019 | K183313 | EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) Euroimmun Us, Inc. | MVM |
| May 24, 2018 | K172582 | EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern Euroimmun Us, Inc. | MOB |
| Apr 20, 2018 | K172252 | EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern Euroimmun Us, Inc. | KTL |
| Apr 20, 2018 | K172244 | EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern Euroimmun Us, Inc. | KTL |
| Dec 10, 2017 | K172722 | Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) Euroimmun Us, Inc. | LSR |
| Aug 25, 2016 | K161513 | Anti-Borrelia burgdorferi US Westernblot (IgG) Euroimmun US | LSR |
| Aug 12, 2016 | K153308 | EUROIMMUN Anti-West Nile Virus ELISA (IgM) Euroimmun Us, Inc. | NOP |
| Aug 10, 2016 | K153303 | EUROIMMUN Anti-West Nile Virus ELISA (IgG) Euroimmun Us, Inc. | NOP |
| May 4, 2015 | K142038 | EUROIMMUN LYME ELISA(IgG/IgM) Euroimmun US | LSR |
| Apr 17, 2015 | K141827 | EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE Euroimmun Us, Inc. | DHN |
| Dec 9, 2014 | K140224 | EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) Euroimmun US | LKO |
| Jun 27, 2014 | K132195 | EUROIMMUN ANTI-PLA2R ELISA (IGG) Euroimmun Us, Inc. | PGV |
| May 29, 2014 | DEN140002 | EUROIMMUN ANTI-PLA2R IFA Euroimmun US | PGV |
| Feb 26, 2014 | K131791 | IFA 40: HEP-20-10 Euroimmun US | DHN |
| Jul 17, 2013 | K123660 | 25-OH VITAMIN D ELISA Euroimmun US | MRG |
| Jul 15, 2013 | K131185 | ANA SCREEN ELISA (IGG) Euroimmun US | LJM |
| Jun 12, 2013 | K123261 | EUROIMMUN ANTI-NRNP/SM ELISA (IGG) Euroimmun US | LKO |
| Apr 12, 2013 | K113439 | EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG) Euroimmun US | NIY |
| Apr 9, 2013 | K112996 | EUROIMMUN ANTI-ENA POOL ELISA (IGG) Euroimmun US | LLL |
| Sep 11, 2012 | K112223 | EUROIMMUN ANTI-LKM-1 ELISA(LGG) Euroimmun US | NBS |
| Sep 11, 2012 | K112221 | EUROIMMUN ANTI-SLA/LP ELISA(LGG) Euroimmun US | NIY |
| Sep 13, 2010 | K100017 | EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM Euroimmun Us, Inc. | OSK |
| Sep 2, 2010 | K092736 | EUROIMMUN ANTI-M2-3E ELISA (IGG) Euroimmun Us, Inc. | DBM |
| Sep 2, 2010 | K091969 | EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG) Euroimmun Us, Inc. | NBO |
| Aug 7, 2009 | K083053 | EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG) Euroimmun Us, Inc. | MST |
| Jul 28, 2009 | K083052 | EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA) Euroimmun Us, Inc. | MST |
| May 20, 2009 | K083850 | EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS Euroimmun Us, Inc. | MOB |
| Apr 15, 2009 | K083381 | EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) Euroimmun Us, Inc. | LRM |
| Apr 7, 2009 | K082130 | EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG) Euroimmun Us, Inc. | MOB |
| Mar 16, 2009 | K083615 | EUROIMMUN ANTI BP 180-4X ELISA (IGG) Euroimmun Us, Inc. | OEG |
| Dec 31, 2007 | K070789 | EUROIMMUN ANTI-CCP ELISA Euroimmun Us, LLC | NHX |
| Jun 28, 2007 | K061239 | EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT Euroimmun Us, LLC | MYF |
| May 22, 2007 | K070763 | EUROIMMUN ANA IFA: HEP-20-10 Euroimmun Us, LLC | DHN |
| Oct 5, 2006 | K061408 | EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT Euroimmun Us, LLC | MVM |
| Sep 8, 2006 | K060700 | EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT. Euroimmun Us, LLC | MOB |
| Feb 16, 2006 | K051489 | EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM Euroimmun Us, LLC | MOB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||