Euroimmun Us, Inc.
FDA 510(k) & PMA Approved Devices — 8 products
Total Devices8
Categories6
Latest FDA decision2020-09-17
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K193115 | EUROIMMUN Anti-BP230-CF ELISA (IgG) | OEG | 2020-09-17 | View |
| 510(k) | K183313 | EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) | MVM | 2019-02-28 | View |
| 510(k) | K172582 | EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern | MOB | 2018-05-24 | View |
| 510(k) | K172244 | EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern | KTL | 2018-04-20 | View |
| 510(k) | K172252 | EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern | KTL | 2018-04-20 | View |
| 510(k) | K172722 | Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) | LSR | 2017-12-10 | View |
| 510(k) | K153308 | EUROIMMUN Anti-West Nile Virus ELISA (IgM) | NOP | 2016-08-12 | View |
| 510(k) | K153303 | EUROIMMUN Anti-West Nile Virus ELISA (IgG) | NOP | 2016-08-10 | View |
No matching devices.