EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern— 510(k) K172582
Substantially EquivalentEuroimmun Us, Inc.
FDA 510(k) clearance K172582 for EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern, Substantially Equivalent on 2018-05-24. 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
- Mountain Lakes, NJ, US
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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
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Data sourced from openFDA. This site is unofficial and independent of the FDA.