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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 the device name listed in this FDA 510(k) record. The listed applicant is George King Bio-Medical, Inc.. It received FDA 510(k) clearance on 2017-02-23 under 510(k) 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. The listed applicant is George King Bio-Medical, Inc.. The 510(k) number is K161316.

When did George King Coumadin Plasma receive FDA 510(k) clearance?

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

Who is the listed applicant for George King Coumadin Plasma?

The FDA 510(k) record lists George King Bio-Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: GGN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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