FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Tina-quant Cardiac high sensitivity CRP III
K Number: K260026
·
Decision Apr 2, 2026
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
18
Applicant Total
183
Review Days
87
Basic Information
- Device Name
- Tina-quant Cardiac high sensitivity CRP III
- K Number
- K260026
- 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
- Date Received
- January 5, 2026
- Decision Date
- April 2, 2026
- Product Code
- NQD
- 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 |
|---|---|---|---|
| NQD | Cardiac C-Reactive Protein, Antigen, Antiserum, And Control | FDA class 2 | Immunology |
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