CRYOcheck Factor VIII Deficient Plasma with VWF
FDA 510(k) K222831 · Precision Biologic, Inc.
510(k) numberK222831
Submission
- Device name
- CRYOcheck Factor VIII Deficient Plasma with VWF
- Applicant
- Precision Biologic, Inc.
Darmouth, CA - Received
- September 19, 2022
- Decision date
- September 13, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|---|
| 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 |
| K031122 | Hemosil Factor X Deficient PlasmaGJT · Traditional | Instrumentation Laboratory CO | 05/19/2003SE |
More from Instrumentation Laboratory CO
| 510(k) | Device | Decision |
|---|---|---|
| K251440 | CRYOcheck Chromogenic Factor VIIIGGP · Traditional | 08/25/2025SE |
| K214002 | CRYOcheck Chromogenic Factor IXGGP · Traditional | 12/23/2022SE |
| K193556 | Cryocheck Hex LAGFO · Traditional | 10/23/2020SE |
| K193204 | Cryocheck Chromogenic Factor VIIIGGP · Traditional | 07/17/2020SE |
| K183440 | CRYOcheck FVIII Inhibitor KitGGP · Traditional | 03/12/2019SE |
| K060284 | Cryocheck Clot ApcrGGW · Traditional | 05/10/2006SE |
| K043571 | Cryocheck Clot SGGP · Traditional | 03/18/2005SE |
| K040987 | Cryocheck Clot CGGP · Traditional | 06/18/2004SE |
| K032804 | Cryocheck Weak Lupus Positive ControlGGC · Traditional | 11/03/2003SE |
| K023991 | Chromocheck Antithrombin 25; Chromocheck Antithrombin 50JBQ · Traditional | 04/28/2003SE |
Questions and answers
When was CRYOcheck Factor VIII Deficient Plasma with VWF cleared by the FDA?
CRYOcheck Factor VIII Deficient Plasma with VWF (K222831) received a 510(k) decision of Substantially Equivalent on September 13, 2023, 359 days after the submission was received.
What is the product code of K222831?
The FDA product code is GJT – Plasma, Coagulation Factor Deficient, a Class II (moderate risk) device regulated under 21 CFR 864.7290.