FDA 510(k)

Genesis Low Temperature Reusable Rigid Container System

K-Number: K153554 · 2016-03-21

Decision Date2016-03-21

Product CodeKCT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Genesis Low Temperature Reusable Rigid Container System is a medical device manufactured by Carefusion 2200, Inc.. It received FDA 510(k) clearance on 2016-03-21 under approval number K153554. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Genesis Low Temperature Reusable Rigid Container System?

Genesis Low Temperature Reusable Rigid Container System is a medical device that received FDA 510(k) clearance on 2016-03-21. It is manufactured by Carefusion 2200, Inc.. The 510(k) number is K153554.

When was Genesis Low Temperature Reusable Rigid Container System approved by the FDA?

Genesis Low Temperature Reusable Rigid Container System received FDA 510(k) clearance on 2016-03-21, under approval number K153554.

What company makes Genesis Low Temperature Reusable Rigid Container System?

Genesis Low Temperature Reusable Rigid Container System is manufactured by Carefusion 2200, Inc..

What is the FDA product code for Genesis Low Temperature Reusable Rigid Container System?

The FDA product code for Genesis Low Temperature Reusable Rigid Container System is KCT.

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Other Devices by Carefusion 2200, Inc.

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Related Devices (Code: KCT)

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Official Source

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