Cryo Check Factor Viii Deficient Plasma
FDA 510(k) K971225 · Precision Biologicals, Inc.
510(k) numberK971225
Submission
- Device name
- Cryo Check Factor Viii Deficient Plasma
- Applicant
- Precision Biologicals, Inc.
Dartmouth, Nova Scotia, CA - Received
- April 2, 1997
- Decision date
- July 17, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GJT – Plasma, Coagulation Factor Deficient
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7290
- Specialty
- Hematology
Other 510(k)s with product code GJT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222831 | CRYOcheck Factor VIII Deficient Plasma with VWFGJT · Traditional | Precision Biologic, Inc. | 09/13/2023SE |
| K180486 | HemosIL Factor XII Deficient PlasmaGJT · Special | Instrumentation Laboratory CO | 03/22/2018SE |
| K102908 | Nofact IxGJT · Traditional | R2 Diagnostics, Inc. | 12/19/2011SE |
| K102851 | Nofact ViiiGJT · Traditional | R2 Diagnostics, Inc. | 12/19/2011SE |
| K110237 | Hemosil Factor Viii Deficient PlasmaGJT · Traditional | Instrumentation Laboratory CO | 07/08/2011SE |
| K050661 | Hemosil Factor II Deficient PlasmaGJT · Traditional | Instrumentation Laboratory CO | 05/02/2005SE |
| K043459 | Hemosil Factor Xii Deficient PlasmaGJT · Traditional | Instrumentation Laboratory CO | 02/09/2005SE |
| K040362 | Diapharma Factor X KitGJT · Traditional | Diapharma Group, Inc. | 07/12/2004SE |
| K034007 | Hemosil Factor Viii Deficient PlasmaGJT · Traditional | Instrumentation Laboratory CO | 02/13/2004SE |
| K031829 | Hemosil Factor Ix Deficient PlasmaGJT · Traditional | Instrumentation Laboratory CO | 07/31/2003SE |
More from Instrumentation Laboratory CO
| 510(k) | Device | Decision |
|---|---|---|
| K982062 | Cryo-Check PNP Platelet Lysate, Model PNP-10GGW · Traditional | 01/13/1999SE |
| K981174 | Cryo Check Factor Xii Deficient Plasma Model FDP12-10 (1.0ML) and FDP12-15 (1.5ML)GJT · Traditional | 01/13/1999SE |
| K981173 | Cryo Check Factor Xi Deficient Plasma, Model FDP11-10 (1.OML) and FDP11-15 (1.5ML)GJT · Traditional | 01/13/1999SE |
| K971219 | Cryo Check Inr Validation SetGGN · Traditional | 08/29/1997SE |
| K971222 | Cryo Check Apc Resistant PlasmaGGN · Traditional | 08/19/1997SE |
| K971223 | Cryo Check Factor V Deficient PlasmaGJT · Traditional | 07/22/1997SE |
| K971227 | Cryo Check Factor X Deficient PlasmaGJT · Traditional | 07/18/1997SE |
| K971226 | Cryo Check Factor Ix Deficient PlasmaGJT · Traditional | 07/18/1997SE |
| K971224 | Cryo Check Factor Vii Deficient PlasmaGJT · Traditional | 07/17/1997SE |
| K951823 | Cryo Check Low Fibrinogen ControlGGN · Traditional | 01/03/1996SE |
Questions and answers
When was Cryo Check Factor Viii Deficient Plasma cleared by the FDA?
Cryo Check Factor Viii Deficient Plasma (K971225) received a 510(k) decision of Substantially Equivalent on July 17, 1997, 106 days after the submission was received.
What is the product code of K971225?
The FDA product code is GJT – Plasma, Coagulation Factor Deficient, a Class II (moderate risk) device regulated under 21 CFR 864.7290.