Coagulation Control Level 1 (Normal)
FDA 510(k) K984129 · Pacific Hemostasis
510(k) numberK984129
Submission
- Device name
- Coagulation Control Level 1 (Normal)
- Applicant
- Pacific Hemostasis
Huntersville, NC, US - Received
- November 18, 1998
- Decision date
- December 1, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GIZ – Plasma, Control, Normal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
Other 510(k)s with product code GIZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K060968 | Stasis - I, II and III; Serathan - a, B; Intrin - Ea, Si Calcium Chloride 0.02M…GIZ · Traditional | Wortham Laboratories, Inc. | 05/15/2007SE |
| K042941 | Dade Behring Heparin Calibrator and ControlsGIZ · Traditional | Dade Behring, Inc. | 12/02/2004SE |
| K023309 | Control Plasma NGIZ · Traditional | Dade Behring, Inc. | 11/01/2002SE |
| K013708 | Reference Check, Catalog NUMBER-RCN-10GIZ · Traditional | Precision Biologic | 12/10/2001SE |
| K003328 | Accuclot Control I, Model A4089GIZ · Traditional | Sigma Diagnostics, Inc. | 03/01/2001SE |
| K001256 | Control Plasma NGIZ · Traditional | Dade Behring, Inc. | 05/24/2000SE |
| K973274 | Accucolor High Calibrator (A3089)GIZ · Traditional | Sigma Diagnostics, Inc. | 10/31/1997SE |
| K961814 | Thrombolytic Assessment System Prothrombin Time Test ControlsGIZ · Traditional | Cardiovascular Diagnostics, Inc. | 08/13/1996SE |
| K941737 | Specialty Assayed CONTROL-1GIZ · Traditional | Helena Laboratories | 10/07/1994SE |
| K935254 | Dvvtest and Dvvconfirm Lupus Anticoagulant Normal and Abnormal Control PlasmaGIZ · Traditional | American Diagnostica, Inc. | 09/19/1994SE |
More from American Diagnostica, Inc.
| 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 |
| K972627 | Pacific Hemostasis Immunodepleted Factor V Deficient Plasma (Thrombosdreen Brand) (100056)GJT · Traditional | 08/13/1997SE |
Questions and answers
When was Coagulation Control Level 1 (Normal) cleared by the FDA?
Coagulation Control Level 1 (Normal) (K984129) received a 510(k) decision of Substantially Equivalent on December 1, 1998, 13 days after the submission was received.
What is the product code of K984129?
The FDA product code is GIZ – Plasma, Control, Normal, a Class II (moderate risk) device regulated under 21 CFR 864.5425.