510(k) K103090
K103090 is an FDA 510(k) premarket notification submitted by Caridianbct, Inc.. for the device "SPECTRA OPTIA R APHERESIS SYSTEM". The FDA issued a decision of Substantially Equivalent on November 19, 2010. The device falls under product code LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic), a Class U device. Caridianbct, Inc.. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 19, 2010
- Date Received
- October 19, 2010
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Separator, Automated, Blood Cell And Plasma, Therapeutic
- Device Class
- Class U
- Regulation Number
- Review Panel
- GU
- Submission Type