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FDA 510(k), K161324, Raycell Mk2
FDA 510(k), K161324, Raycell Mk2
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510(K) Number: K161324
Device Name: Raycell Mk2
Manufacturer: Best Theratronics Limited
Device Classification Name: irradiator, blood to prevent graft versus host disease
Regulation Number:
Classification Product Code: MOT
Date Received: 05/11/2016
Decision Date: 08/12/2016
Regulation Medical Specialty:
Device Name: Raycell Mk2
Manufacturer: Best Theratronics Limited
Device Classification Name: irradiator, blood to prevent graft versus host disease
Regulation Number:
Classification Product Code: MOT
Date Received: 05/11/2016
Decision Date: 08/12/2016
Regulation Medical Specialty:
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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