FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
EDIA ANTI-CCP
K Number: K062045
·
Decision Dec 4, 2006
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
20
Applicant Total
6
Review Days
138
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Basic Information
- Device Name
- EDIA ANTI-CCP
- K Number
- K062045
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5775
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Euro-Diagnostica AB
- Date Received
- July 19, 2006
- Decision Date
- December 4, 2006
- Product Code
- NHX
- 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 |
|---|---|---|---|
| NHX | Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | FDA class 2 | Immunology |
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Other Clearances by Euro-Diagnostica AB
| K Number | Device Name | ||
|---|---|---|---|
| K093908 | CCPOINT | Dec 1, 2010 | Substantially Equivalent |
| K091657 | IMMUNOSCAN CCPLUS | Nov 19, 2009 | Substantially Equivalent |
| K971464 | IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT | Oct 29, 1997 | Substantially Equivalent |
| K971690 | IMMUNOSCAN PR3-ANCA | Oct 29, 1997 | Substantially Equivalent |
| K971689 | IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT | Oct 29, 1997 | Substantially Equivalent |