EUROIMMUN ANTI-CCP ELISA— 510(k) K070789
Substantially EquivalentEuroimmun Us, LLC
FDA 510(k) clearance K070789 for EUROIMMUN ANTI-CCP ELISA, Substantially Equivalent on 2007-12-31. Applicant: Euroimmun Us, LLC. Device class: 2.
Clearance details
- Applicant
- Euroimmun Us, LLC
- Product code
- Code NHX
- Device class
- Class 2
- Regulation
- 21 CFR 866.5775
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boonton Township, NJ, US
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More clearances from Euroimmun Us, LLC
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- K060700 — EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.
- K051489 — EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM
Data sourced from openFDA. This site is unofficial and independent of the FDA.