510(k) K050245
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 2005
- Date Received
- February 2, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Immunomagnetic, Circulating Cancer Cell, Enumeration
- Device Class
- Class II
- Regulation Number
- 866.6020
- Review Panel
- PA
- Submission Type
In vitro diagnostic device to aid in the enumeration of immunomagnetically selected and fluorescently identified circulating tumor cells of epithelial origin in whole blood for prediction of cancer progression and survival.