Cell-Dyn 08H59-01
Cell-Dyn 08H59-01 (08H5901) is a Class II device made by Abbott Laboratories, cleared under FDA 510(k) K901875 on 30 May 1990 and listed in FDA GUDID since 6 Jun 2016 (UDI-DI 00380740017101), 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 | Number00380740017101 | Date6 Jun 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK901875 | Date30 May 1990 | StatusActive |
Official records
- AccessGUDID record 00380740017101
- FDA 510(k) database K901875
Across registries
- FDA 510(k) K901875 decided 30 May 1990 Active
- FDA GUDID UDI-DI 00380740017101 listed 6 Jun 2016 Listed
Timeline
- Cleared FDA 510(k) K901875
- Listed FDA GUDID 00380740017101
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- Withdrawn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
- 08H59-01, 08H5901
- Primary DI / UDI-DI
- 00380740017101
- 510(k) Number
- FDA product code
- JCN
- GMDN term
- Full blood count IVD, control
- Device class
- Class II
- Regulation number
- 864.8625
- GUDID distribution status
- In Commercial Distribution
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