EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern— 510(k) K172244
Substantially EquivalentEuroimmun Us, Inc.
FDA 510(k) clearance K172244 for EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern, Substantially Equivalent on 2018-04-20. Applicant: Euroimmun Us, Inc.. Device class: 2.
Clearance details
- Applicant
- Euroimmun Us, Inc.
- Product code
- Code KTL
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mountain Lakes, NJ, US
Recent devices under product code KTL
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- K172722 — Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)
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Data sourced from openFDA. This site is unofficial and independent of the FDA.