Cell-Dyn 08H58-02
Cell-Dyn 08H58-02 (08H5802) is a Class II device made by Abbott Laboratories, cleared under FDA 510(k) K000945 on 18 Apr 2000 and listed in FDA GUDID since 6 Jun 2016 (UDI-DI 00380740017095), 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 | Number00380740017095 | Date6 Jun 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK000945 | Date18 Apr 2000 | StatusActive |
Official records
- AccessGUDID record 00380740017095
- FDA 510(k) database K000945
Across registries
- FDA 510(k) K000945 decided 18 Apr 2000 Active
- FDA GUDID UDI-DI 00380740017095 listed 6 Jun 2016 Listed
Timeline
- Cleared FDA 510(k) K000945
- Listed FDA GUDID 00380740017095
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cell-Dyn
- Generic name
- Full blood count IVD, control
- Model / Ref / Catalog
- 08H58-02, 08H5802
- Primary DI / UDI-DI
- 00380740017095
- 510(k) Number
- FDA product code
- GLQ
- GMDN term
- Full blood count IVD, control
- Device class
- Class II
- Regulation number
- 864.8625
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Full blood count IVD, control.
- Research and Diagnostic Systems CL020 by RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
- Research and Diagnostic Systems CL037 by RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
- ADVIA® 120/2120/2120i TESTpoint Low Control 10312287 T03-3686-54 by Siemens Healthcare Diagnostics Inc.
- ADVIA® 120/2120/2120i TESTpoint CSF Control Kit 10314243 T03-4485-01 by Siemens Healthcare Diagnostics Inc.
- CitoCBC Control 1310 by Cytochip, Inc.
- XN CHECK NSH-100G BV166979 by SYSMEX CORPORATION
- DxH 500 Series Control B36872 by BECKMAN COULTER IRELAND INC.
- Para 12 Plus 218913 by Streck
- XN CHECK NSN-100G CV649926 by SYSMEX CORPORATION