Tina-quant Cystatin C Gen.2— 510(k) K161817
Substantially EquivalentRoche Diagnostics Operations (Rdo)
FDA 510(k) clearance K161817 for Tina-quant Cystatin C Gen.2, Substantially Equivalent on 2016-07-27. Applicant: Roche Diagnostics Operations (Rdo). Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Operations (Rdo)
- 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
- Special
- Location
- Indianapolis, IN, US
Recent devices under product code NDY
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