510(k) K132429
K132429 is an FDA 510(k) premarket notification submitted by Terumobct, Inc. for the device "SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET". The FDA issued a decision of Substantially Equivalent on December 6, 2013. 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
- December 6, 2013
- Date Received
- August 5, 2013
- Clearance Type
- Traditional
- 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