FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
CRYOcheck Factor VIII Deficient Plasma with VWF
K Number: K222831
·
Decision Sep 13, 2023
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
78
Applicant Total
7
Review Days
359
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Basic Information
- Device Name
- CRYOcheck Factor VIII Deficient Plasma with VWF
- K Number
- K222831
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Precision Biologic, Inc.
- Date Received
- September 19, 2022
- Decision Date
- September 13, 2023
- Product Code
- GJT
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GJT | Plasma, Coagulation Factor Deficient | FDA class 2 | Hematology |
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Other Clearances by Precision Biologic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251440 | CRYOcheck Chromogenic Factor VIII | Aug 25, 2025 | Substantially Equivalent |
| K214002 | CRYOcheck Chromogenic Factor IX | Dec 23, 2022 | Substantially Equivalent |
| K183440 | CRYOcheck FVIII Inhibitor Kit | Mar 12, 2019 | Substantially Equivalent |
| K060284 | CRYOCHECK CLOT APCR | May 10, 2006 | Substantially Equivalent |
| K043571 | CRYOCHECK CLOT S | Mar 18, 2005 | Substantially Equivalent |
| K040987 | CRYOCHECK CLOT C | Jun 18, 2004 | Substantially Equivalent |