FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT
K Number: K052591
·
Decision Feb 9, 2006
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
125
Applicant Total
36
Review Days
141
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Basic Information
- Device Name
- NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT
- K Number
- K052591
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clinical Data, Inc.
- Date Received
- September 21, 2005
- Decision Date
- February 9, 2006
- Product Code
- DCK
- Advisory Committee
- Immunology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | FDA class 2 | Immunology |
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