CVA for CellDyn 291720
by Streck
CVA for CellDyn 291720 is a Class II device made by Streck, cleared under FDA 510(k) K960557 on 3 Apr 1996 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00844509001591), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00844509001591 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK960557 | Date3 Apr 1996 | StatusActive |
Official records
- AccessGUDID record 00844509001591
- FDA 510(k) database K960557
Across registries
- FDA 510(k) K960557 decided 3 Apr 1996 Active
- FDA GUDID UDI-DI 00844509001591 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K960557
- Listed FDA GUDID 00844509001591
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CVA for CellDyn
- Generic name
- Full blood count IVD, control
- Model / Ref / Catalog
- 291720
- Primary DI / UDI-DI
- 00844509001591
- FDA product code
- JPK
- GMDN term
- Full blood count IVD, control
- Device class
- Class II
- Regulation number
- 864.8625
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 3.0 Milliliter
Similar devices in this category
Other devices filed under Full blood count IVD, control.
- Research and Diagnostic Systems CL027 by RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
- Research and Diagnostic Systems CL010P by RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
- XN CHECK NSN-100G CV649926 by SYSMEX CORPORATION
- ADVIA® 560 Control 11170854 by Siemens Healthcare Diagnostics Inc.
- XN CHECK NSL-100G AF640985 by SYSMEX CORPORATION
- Alinity 04U7212 by Abbott
- ADVIA® 120/2120/2120i 3-in-1 TESTpoint High Control 10318905 T03-4418-54 by Siemens Healthcare Diagnostics Inc.
- CitoCBC Control 1310 by Cytochip, Inc.
- DxH 500 Series Control B36872 by BECKMAN COULTER IRELAND INC.
- Alinity 04U7206 by Abbott