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FDA 510(k), K183081, Spectra Optia Apheresis System
FDA 510(k), K183081, Spectra Optia Apheresis System
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510(K) Number: K183081
Device Name: Spectra Optia Apheresis System
Manufacturer: Terumo BCT, Inc.
Device Classification Name: Separator, Automated, Blood Cell And Plasma, Therapeutic
Regulation Number:
Classification Product Code: LKN
Date Received: 11/06/2018
Decision Date: 02/05/2019
Regulation Medical Specialty:
Device Name: Spectra Optia Apheresis System
Manufacturer: Terumo BCT, Inc.
Device Classification Name: Separator, Automated, Blood Cell And Plasma, Therapeutic
Regulation Number:
Classification Product Code: LKN
Date Received: 11/06/2018
Decision Date: 02/05/2019
Regulation Medical Specialty:
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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