TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET— 510(k) K080811
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K080811 for TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET, Substantially Equivalent on 2008-06-20. Applicant: Roche Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code NDY
- Device class
- Class 2
- Regulation
- 21 CFR 862.1225
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code NDY
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