e-CHECK 199-4004-1
e-CHECK 199-4004-1 is a Class II device made by Sysmex Corporation, cleared under FDA 510(k) K994388 on 14 Jan 2000 and listed in FDA GUDID since 5 Aug 2016 (UDI-DI 14987562460288), active as of 12 Nov 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 | Number14987562460288 | Date5 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK994388 | Date14 Jan 2000 | StatusActive |
Official records
- AccessGUDID record 14987562460288
- FDA 510(k) database K994388
Across registries
- FDA 510(k) K994388 decided 14 Jan 2000 Active
- FDA GUDID UDI-DI 14987562460288 listed 5 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K994388
- Listed FDA GUDID 14987562460288
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- e-CHECK
- Generic name
- Full blood count IVD, control
- Model / reference
- 199-4004-1
- Primary DI / UDI-DI
- 14987562460288
- 510(k) Number
- FDA product code
- JPK, GLQ
- GMDN term
- Full blood count IVD, control
- Device class
- Class II
- Regulation number
- 864.8625
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 4.5 Milliliter
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