EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)— 510(k) K082130
Substantially EquivalentEuroimmun Us, Inc.
FDA 510(k) clearance K082130 for EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG), Substantially Equivalent on 2009-04-07. Applicant: Euroimmun Us, Inc.. Device class: 2.
Clearance details
- Applicant
- Euroimmun Us, Inc.
- Product code
- Code MOB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morristown, NJ, US
Recent devices under product code MOB
view all- K261466 — Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM
- K243776 — Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)
- K172582 — EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern
- K172461 — AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin
- K173792 — EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay
More clearances from Euroimmun Us, Inc.
view all- K193115 — EUROIMMUN Anti-BP230-CF ELISA (IgG)
- K183313 — EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)
- 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.