510(k) K091741
K091741 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "TINA-QUANT CERULOPLASMIN". The FDA issued a decision of Substantially Equivalent on March 18, 2010. The device falls under product code CHN (Immunochemical, Ceruloplasmin), a Class II device regulated under 21 CFR 866.5210. Roche Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 2010
- Date Received
- June 16, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Immunochemical, Ceruloplasmin
- Device Class
- Class II
- Regulation Number
- 866.5210
- Review Panel
- IM
- Submission Type