FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WIESLAB CAP MPO-ANCA
K Number: K051455
·
Decision Nov 23, 2005
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
73
Applicant Total
3
Review Days
174
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Basic Information
- Device Name
- WIESLAB CAP MPO-ANCA
- K Number
- K051455
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Eurodiagnostica
- Date Received
- June 2, 2005
- Decision Date
- November 23, 2005
- Product Code
- MOB
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | FDA class 2 | Immunology |
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