510(k) K141143
K141143 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET". The FDA issued a decision of Substantially Equivalent on July 17, 2014. The device falls under product code NDY (Test, Cystatin C), a Class II device regulated under 21 CFR 862.1225. Roche Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 2014
- Date Received
- May 2, 2014
- Clearance Type
- Traditional
- 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