Pacific Hemostasis
Medical device manufacturer in Huntersville, NC.
29510(k) clearances
0PMA approvals
0recalls
Device types
- GJS Test, Time, Prothrombin 5
- GGN Plasma, Coagulation Control 5
- GHM Test, Sickle Cell 2
- GJT Plasma, Coagulation Factor Deficient 2
- GGC Control, Plasma, Abnormal 2
- KQG Instrument, Coagulation 2
- JOZ System, Automated Platelet Aggregation 1
- KQJ System, Fibrinogen Determination 1
- GGW Test, Time, Partial Thromboplastin 1
- JBQ Antithrombin Iii Quantitation 1
- DHX System, Test, Carcinoembryonic Antigen 1
- GIT Reagent & Control, Partial Thromboplastin… 1
- GIS Test, Fibrinogen 1
- GHH Fibrin Split Products 1
- LCP Assay, Glycosylated Hemoglobin 1
- GFO Activated Partial Thromboplastin 1
- GIZ Plasma, Control, Normal 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K000679 | Thrombostrate Control PlasmasGGN · Traditional | 03/24/2000SE |
| 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 |
| K971428 | Coagulation Control Plasma(Abnormal)Level 0GGN · Traditional | 06/17/1997SE |
| K940082 | Thromboscreen Thromboplastin-DsGJS · Traditional | 02/14/1995SE |
| K891337 | Thromboscreen Aptt ReagentGFO · Traditional | 04/21/1989SE |
| K872217 | Thromboscreen Joshua Hemoglobin S Screening KitGHM · Traditional | 07/31/1987SE |
| K864643 | Glycoscreen Glycosylated Hemoglobin Assay KitLCP · Traditional | 04/28/1987SE |
| K854079 | Thrombo Screen Sickle Cell Assay SetGHM · Traditional | 10/31/1985SE |
| K852512 | Thrombo Screeen Fibrin Degradation Product KitGHH · Traditional | 09/17/1985SE |
| K834086 | Contact-K Aptt ReagentGGN · Traditional | 02/03/1984SE |
| K820450 | ThromboscreenGIT · Traditional | 03/26/1982SE |
| K812658 | Cea Control PlasmaDHX · Traditional | 09/29/1981SE |
| K812215 | Antithrombin III Screen KitJBQ · Traditional | 09/01/1981SE |
| K810350 | ThromboplastinGJS · Traditional | 04/14/1981SE |
| K801460 | Pacific Hemostasis Thrombo-Screen KapttGGW · Traditional | 07/28/1980SE |
| K800826 | Fibrinogen ScreenKQJ · Traditional | 05/30/1980SE |
| K800146 | Platelet Aggregation ReagentsJOZ · Traditional | 02/05/1980SE |
| K791022 | Prothrombin Reference Plasma (Human)GJS · Traditional | 07/24/1979SE |
| K791023 | Prothrombin Free Beef Plasma (PFB)GJS · Traditional | 06/28/1979SE |
| K781880 | Assay Kit, Thrombo-ScreenGIS · Traditional | 12/04/1978SE |