510(k) K062114
K062114 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "CERULOPLASMIN, MODEL 2055953". The FDA issued a decision of Substantially Equivalent on January 31, 2007. The device falls under product code CHN (Immunochemical, Ceruloplasmin), a Class II device regulated under 21 CFR 866.5210. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 2007
- Date Received
- July 24, 2006
- 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