EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS— 510(k) K083850
Substantially EquivalentEuroimmun Us, Inc.
FDA 510(k) clearance K083850 for EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS, Substantially Equivalent on 2009-05-20. 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
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- 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)
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- 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.