510(k) K161817
K161817 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Operations (Rdo) for the device "Tina-quant Cystatin C Gen.2". The FDA issued a decision of Substantially Equivalent on July 27, 2016. The device falls under product code NDY (Test, Cystatin C), a Class II device regulated under 21 CFR 862.1225. Roche Diagnostics Operations (Rdo) has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 2016
- Date Received
- July 1, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Cystatin C
- Device Class
- Class II
- Regulation Number
- 862.1225
- Review Panel
- CH
- Submission Type