FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01
K Number: K061165
·
Decision Aug 3, 2006
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
20
Applicant Total
1
Review Days
99
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Basic Information
- Device Name
- ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01
- K Number
- K061165
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5775
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sweden Diagnostics (Us), Inc.
- Date Received
- April 26, 2006
- Decision Date
- August 3, 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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