510(k) K153601
K153601 is an FDA 510(k) premarket notification submitted by Terumobct, Inc. for the device "Spectra Optia Apheresis System". The FDA issued a decision of Substantially Equivalent on January 14, 2016. The device falls under product code LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic), a Class U device. Terumobct, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 14, 2016
- Date Received
- December 16, 2015
- 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