FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
CRYOCHECK CLOT APCR
K Number: K060284
·
Decision May 10, 2006
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
31
Applicant Total
7
Review Days
96
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Basic Information
- Device Name
- CRYOCHECK CLOT APCR
- K Number
- K060284
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7925
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Precision Biologic, Inc.
- Date Received
- February 3, 2006
- Decision Date
- May 10, 2006
- Product Code
- GGW
- 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 |
|---|---|---|---|
| GGW | Test, Time, Partial Thromboplastin | 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 |
| K222831 | CRYOcheck Factor VIII Deficient Plasma with VWF | Sep 13, 2023 | Substantially Equivalent |
| K214002 | CRYOcheck Chromogenic Factor IX | Dec 23, 2022 | Substantially Equivalent |
| K183440 | CRYOcheck FVIII Inhibitor Kit | Mar 12, 2019 | Substantially Equivalent |
| K043571 | CRYOCHECK CLOT S | Mar 18, 2005 | Substantially Equivalent |
| K040987 | CRYOCHECK CLOT C | Jun 18, 2004 | Substantially Equivalent |