George King Coumadin Plasma
FDA 510(k) K161316 · George King Bio-Medical, Inc.
510(k) numberK161316
Submission
- Device name
- George King Coumadin Plasma
- Applicant
- George King Bio-Medical, Inc.
Overland Park, KS, US - Received
- May 11, 2016
- Decision date
- February 23, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGN – Plasma, Coagulation Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
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| K163498 | VALIDATE Heparin Calibration Verification/Linearity Test KitGGN · Traditional | Maine Standards Company, LLC | 03/16/2017SE |
| K162705 | VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitGGN · Traditional | Maine Standards Company, LLC | 01/05/2017SE |
| K152961 | VALIDATE D-Dimer Calibration Verification/Linearity Test KitGGN · Traditional | Maine Standards Company, LLC | 06/03/2016SE |
| K150144 | VisuCon-F Low Fibrinogen Control PlasmaGGN · Traditional | Affinity Biologicals, Inc. | 03/06/2016SE |
| K142132 | Pool NormGGN · Traditional | Diagnostics Stago S.A.S. | 12/12/2014SE |
| K133582 | Hemosil D-Dimer HS 500 ControlGGN · Traditional | Instrumentation Laboratory | 08/15/2014SE |
| K120977 | Directcheck Control for Hemochron Jr. Microcoagulation Systems Act-Lr Cuvette…GGN · Traditional | International Technidyne Corp. | 07/03/2013SE |
| K120900 | I-Stat PT Control Leviel 1 I-Stat PT Control Level 2GGN · Traditional | Cliniqa Corporation | 05/31/2013SE |
| K120014 | Sta- Coag Control (N+Abn) PlusGGN · Traditional | Diagnostica Stago, Inc. | 03/14/2013SE |
More from Diagnostica Stago, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K945855 | A-Fact, Abnormal Factor Assay ControlGGN · Traditional | 10/24/1995SE |
| K945854 | B-Fact, Borderline Factor Assay ControlGGN · Traditional | 10/24/1995SE |
| K945857 | Protein C Deficient PlasmaGJT · Traditional | 10/20/1995SE |
| K945856 | Positive Lupus Anticoagulant PlasmaGGC · Traditional | 10/05/1995SE |
Questions and answers
When was George King Coumadin Plasma cleared by the FDA?
George King Coumadin Plasma (K161316) received a 510(k) decision of Substantially Equivalent on February 23, 2017, 288 days after the submission was received.
What is the product code of K161316?
The FDA product code is GGN – Plasma, Coagulation Control, a Class II (moderate risk) device regulated under 21 CFR 864.5425.