Thrombostrate Control Plasmas
FDA 510(k) K000679 · Pacific Hemostasis
510(k) numberK000679
Submission
- Device name
- Thrombostrate Control Plasmas
- Applicant
- Pacific Hemostasis
Huntersville, NC, US - Received
- February 29, 2000
- Decision date
- March 24, 2000
- 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
Other 510(k)s with product code GGN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K170864 | VALIDATE D-Dimer Calibration Verification / Linearity Test KitGGN · Traditional | Maine Standards Company, LLC | 06/21/2017SE |
| K163498 | VALIDATE Heparin Calibration Verification/Linearity Test KitGGN · Traditional | Maine Standards Company, LLC | 03/16/2017SE |
| K161316 | George King Coumadin PlasmaGGN · Traditional | George King Bio-Medical, Inc. | 02/23/2017SE |
| 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 |
More from Cliniqa Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K994100 | Pacific Hemostasis Thromboplastin DGJS · Traditional | 02/18/2000SE |
| K992130 | Pacific Hemostasis Thromboscreen 400CKQG · Traditional | 09/03/1999SE |
| K992279 | Heparin Control Plasma Level 2GGN · Traditional | 08/26/1999SE |
| K992278 | Heparin Control Plasma Level 1GGN · Traditional | 08/26/1999SE |
| K991321 | Pacific Hemostasis Thromboscreen 200KQG · Traditional | 06/21/1999SE |
| K990046 | Pacific Hemostasis Immunodepleted Factor Viii Deficient PlasmaGJT · Traditional | 02/17/1999SE |
| K984131 | Coagulation Control Level 3 (Abnormal)GGC · Traditional | 12/01/1998SE |
| K984130 | Coagulation Control Level 2 (Abnormal)GGC · Traditional | 12/01/1998SE |
| K984129 | Coagulation Control Level 1 (Normal)GIZ · Traditional | 12/01/1998SE |
| K972627 | Pacific Hemostasis Immunodepleted Factor V Deficient Plasma (Thrombosdreen Brand) (100056)GJT · Traditional | 08/13/1997SE |
Questions and answers
When was Thrombostrate Control Plasmas cleared by the FDA?
Thrombostrate Control Plasmas (K000679) received a 510(k) decision of Substantially Equivalent on March 24, 2000, 24 days after the submission was received.
What is the product code of K000679?
The FDA product code is GGN – Plasma, Coagulation Control, a Class II (moderate risk) device regulated under 21 CFR 864.5425.