FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMUNOSCAN RA ANTI-CCP TEST SYSTEM
K Number: K052133
·
Decision Dec 12, 2005
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
20
Applicant Total
3
Review Days
129
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Basic Information
- Device Name
- IMMUNOSCAN RA ANTI-CCP TEST SYSTEM
- K Number
- K052133
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5775
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Eurodiagnostica
- Date Received
- August 5, 2005
- Decision Date
- December 12, 2005
- 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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