510(k) K060110
K060110 is an FDA 510(k) premarket notification submitted by Immunicon Corp. for the device "CELLTRACKS ANALYZER II". The FDA issued a decision of Substantially Equivalent on March 16, 2006. The device falls under product code NQI (System, Immunomagnetic, Circulating Cancer Cell, Enumeration), a Class II device regulated under 21 CFR 866.6020. Immunicon Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 2006
- Date Received
- January 17, 2006
- 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.