CRYOcheck Chromogenic Factor VIII
FDA 510(k) clearance K251440 · decided 2025-08-25
Clearance details
- K-number
- K251440
- Device name
- CRYOcheck Chromogenic Factor VIII
- Applicant
- Precision Biologic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-05-09
- Decision date
- 2025-08-25
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- GGP
- Device class
- 2
- Regulation number
- 864.7290
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Dartmouth, CA
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Precision Biologic
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HemosIL Chromogenic Factor IX (K230852) | Instrumentation Laboratory Company | 2023-12-13 |
| vWF Ag (K220728) | Siemens Healthcare Diagnostics Products GmbH | 2023-06-02 |
| CRYOcheck Chromogenic Factor IX (K214002) | Precision Biologic, Inc. | 2022-12-23 |
| HemosIL von Willebrand Factor Antigen (K223402) | Instrumentation Laboratory CO | 2022-12-09 |
| HemosIL von Willebrand Factor Antigen (K200033) | Instrumentation Laboratory CO | 2020-08-19 |
| Cryocheck Chromogenic Factor VIII (K193204) | Precision Biologic | 2020-07-17 |
| CRYOcheck FVIII Inhibitor Kit (K183440) | Precision Biologic, Inc. | 2019-03-12 |
| INNOVANCE Free PS Ag (K181525) | Siemens Healthcare Diagnostics Products GmbH | 2018-09-07 |
| HEMOSIL VON WILLEBRAND ACTIVITY ASSAY (K133005) | Instrumentation Laboratory CO | 2014-03-13 |
| HEMOSIL PROTEIN S ACTIVITY ASSAY (K102164) | Instrumentation Laboratory CO | 2011-03-17 |
| STA LIATEST FREE PS (K092170) | Diagnostica Stago, Inc. | 2009-12-22 |
| THROMBO TEK PSE, MODEL 90-480 (K082631) | R2 Diagnostics, Inc. | 2008-12-17 |
Recalls involving this device
No recalls on record reference this clearance.