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FDA 510(k)

Spectra Optia Apheresis System

K-Number: K153601 · 2016-01-14

ApplicantTerumobct, Inc.
Decision Date2016-01-14
Product CodeLKN
DecisionSubstantially Equivalent

Device Summary

Spectra Optia Apheresis System is a medical device manufactured by Terumobct, Inc.. It received FDA 510(k) clearance on 2016-01-14 under approval number K153601. The device is classified under product code LKN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spectra Optia Apheresis System?

Spectra Optia Apheresis System is a medical device that received FDA 510(k) clearance on 2016-01-14. It is manufactured by Terumobct, Inc.. The 510(k) number is K153601.

When was Spectra Optia Apheresis System approved by the FDA?

Spectra Optia Apheresis System received FDA 510(k) clearance on 2016-01-14, under approval number K153601.

What company makes Spectra Optia Apheresis System?

Spectra Optia Apheresis System is manufactured by Terumobct, Inc..

What is the FDA product code for Spectra Optia Apheresis System?

The FDA product code for Spectra Optia Apheresis System is LKN.

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Related PubMed Literature

PMID: 40624055 Establishment of a clinical workflow for in vivo Raman spectroscopy during head and neck cancer surgery. Scientific reports (2025)

Other Devices by Terumobct, Inc.

K162365T-Cuff K181049Spectra Optia Apheresis System K172590Spectra Optia Apheresis System K183081Spectra Optia Apheresis System

Related Devices (Code: LKN)

K180615AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer AdapterFresenius Kabi USA,Llc K181049Spectra Optia Apheresis SystemTerumobct, Inc. K172590Spectra Optia Apheresis SystemTerumobct, Inc. K192150AMICUS Separator SystemFresenius Kabi AG K183081Spectra Optia Apheresis SystemTerumobct, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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