VARELISA MPO ANCA, MODEL 17648/17696— 510(k) K041040
Substantially EquivalentSweden Diagnostics (Germany) GmbH
FDA 510(k) clearance K041040 for VARELISA MPO ANCA, MODEL 17648/17696, Substantially Equivalent on 2004-06-16. Applicant: Sweden Diagnostics (Germany) GmbH. Device class: 2.
Clearance details
- Applicant
- Sweden Diagnostics (Germany) GmbH
- 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
- Freiburg, DE
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More clearances from Sweden Diagnostics (Germany) GmbH
view allData sourced from openFDA. This site is unofficial and independent of the FDA.