Tina-quant Cardiac high sensitivity CRP III— 510(k) K260026
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K260026 for Tina-quant Cardiac high sensitivity CRP III, Substantially Equivalent on 2026-04-02. Applicant: Roche Diagnostics. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code NQD
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
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More clearances from Roche Diagnostics
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