Spectra Optia Apheresis System

Separator, Automated, Blood Cell And Plasma, Therapeutic

Terumo BCT, Inc.

The following data is part of a premarket notification filed by Terumo Bct, Inc. with the FDA for Spectra Optia Apheresis System.

Pre-market Notification Details

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• Device ID: K183081
• 510k Number: K183081
• Device Name: Spectra Optia Apheresis System
• Classification: Separator, Automated, Blood Cell And Plasma, Therapeutic
• Applicant: Terumo BCT, Inc. 10811 W. Collins Avenue Lakewood, CO 80215
• Contact: Nicholas Wong
• Correspondent: Nicholas Wong; Terumo BCT, Inc. 10811 W. Collins Avenue Lakewood, CO 80215
• Product Code: LKN
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-11-06
• Decision Date: 2019-02-05
• Summary: summary