510(k) K051456
K051456 is an FDA 510(k) premarket notification submitted by Sentinel Ch. Srl for the device "SENTINEL CERULOPLASMIN". The FDA issued a decision of Substantially Equivalent on October 21, 2005. The device falls under product code JFR (Indirect Copper Assay, Ceruloplasmin), a Class II device regulated under 21 CFR 866.5210. Sentinel Ch. Srl has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 2005
- Date Received
- June 2, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Indirect Copper Assay, Ceruloplasmin
- Device Class
- Class II
- Regulation Number
- 866.5210
- Review Panel
- IM
- Submission Type