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FDA 510(k)

George King Coumadin Plasma

K-Number: K161316 · 2017-02-23

ApplicantGeorge King Bio-Medical, Inc.
Decision Date2017-02-23
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

George King Coumadin Plasma is a medical device manufactured by George King Bio-Medical, Inc.. It received FDA 510(k) clearance on 2017-02-23 under approval number K161316. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the George King Coumadin Plasma?

George King Coumadin Plasma is a medical device that received FDA 510(k) clearance on 2017-02-23. It is manufactured by George King Bio-Medical, Inc.. The 510(k) number is K161316.

When was George King Coumadin Plasma approved by the FDA?

George King Coumadin Plasma received FDA 510(k) clearance on 2017-02-23, under approval number K161316.

What company makes George King Coumadin Plasma?

George King Coumadin Plasma is manufactured by George King Bio-Medical, Inc..

What is the FDA product code for George King Coumadin Plasma?

The FDA product code for George King Coumadin Plasma is GGN.

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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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