FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRP HS TEST SYSTEM
K Number: K003400
·
Decision May 10, 2001
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
69
Applicant Total
264
Review Days
190
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Basic Information
- Device Name
- CRP HS TEST SYSTEM
- K Number
- K003400
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- November 1, 2000
- Decision Date
- May 10, 2001
- Product Code
- DCN
- 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 |
|---|---|---|---|
| DCN | System, Test, C-Reactive Protein | FDA class 2 | Immunology |
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