Lyphochek 279X
Lyphochek 279X is a Class I device made by Bio-Rad Laboratories, cleared under FDA 510(k) K072721 on 11 Dec 2007 and listed in FDA GUDID since 14 Sep 2020 (UDI-DI 00847661005636), 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 | Number00847661005636 | Date14 Sep 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK072721 | Date11 Dec 2007 | StatusActive |
Official records
- AccessGUDID record 00847661005636
- FDA 510(k) database K072721
Across registries
- FDA 510(k) K072721 decided 11 Dec 2007 Active
- FDA GUDID UDI-DI 00847661005636 listed 14 Sep 2020 Listed
Timeline
- Cleared FDA 510(k) K072721
- Listed FDA GUDID 00847661005636
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Lyphochek
- Generic name
- Multiple immunosuppressant therapeutic drug monitoring IVD, control
- Model / Ref / Catalog
- 279X
- Primary DI / UDI-DI
- 00847661005636
- 510(k) Number
- FDA product code
- DIF
- GMDN term
- Multiple immunosuppressant therapeutic drug monitoring IVD, control
- Device class
- Class I
- Regulation number
- 862.3280
- GUDID distribution status
- In Commercial Distribution
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