Coagulation Control Level 3 (Abnormal)
FDA 510(k) K984131 · Pacific Hemostasis
510(k) numberK984131
Submission
- Device name
- Coagulation Control Level 3 (Abnormal)
- 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
- GGC – Control, Plasma, Abnormal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
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| K023312 | Control Plasma PGGC · Traditional | Dade Behring, Inc. | 11/01/2002SE |
| K020878 | Lyphochek Hemostasis, Models 798, 799GGC · Traditional | Bio-Rad | 04/15/2002SE |
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| K012422 | K-Assay D-Dimer ControlsGGC · Traditional | Kamiya Biomedical Co. | 08/21/2001SE |
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More from Sigma Diagnostics, 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 |
| 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 Coagulation Control Level 3 (Abnormal) cleared by the FDA?
Coagulation Control Level 3 (Abnormal) (K984131) 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 K984131?
The FDA product code is GGC – Control, Plasma, Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.5425.