EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)— 510(k) K183313
Substantially EquivalentEuroimmun Us, Inc.
FDA 510(k) clearance K183313 for EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG), Substantially Equivalent on 2019-02-28. Applicant: Euroimmun Us, Inc.. Device class: 2.
Clearance details
- Applicant
- Euroimmun Us, Inc.
- Product code
- Code MVM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mountain Lakes, NJ, US
Recent devices under product code MVM
view allMore clearances from Euroimmun Us, Inc.
view all- K193115 — EUROIMMUN Anti-BP230-CF ELISA (IgG)
- K172582 — EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern
- K172244 — EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern
- K172252 — EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern
- K172722 — Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)
Data sourced from openFDA. This site is unofficial and independent of the FDA.