EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM— 510(k) K051489
Substantially EquivalentEuroimmun Us, LLC
FDA 510(k) clearance K051489 for EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM, Substantially Equivalent on 2006-02-16. Applicant: Euroimmun Us, LLC. Device class: 2.
Clearance details
- Applicant
- Euroimmun Us, LLC
- 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
- Boonton Twp, NJ, US
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More clearances from Euroimmun Us, LLC
view allData sourced from openFDA. This site is unofficial and independent of the FDA.