Ck-Mb CK4043
Ck-Mb CK4043 is a Class II device made by Randox Laboratories, Ltd., cleared under FDA 510(k) K123977 on 21 Nov 2013 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 05055273213973), active as of 22 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 | Number05055273213973 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK123977 | Date21 Nov 2013 | StatusActive |
Official records
- AccessGUDID record 05055273213973
- FDA 510(k) database K123977
Across registries
- FDA 510(k) K123977 decided 21 Nov 2013 Active
- FDA GUDID UDI-DI 05055273213973 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K123977
- Listed FDA GUDID 05055273213973
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ck-Mb
- Generic name
- Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent
- Model / Ref / Catalog
- CK4043
- Primary DI / UDI-DI
- 05055273213973
- 510(k) Number
- FDA product code
- CGS
- GMDN term
- Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent
- Device class
- Class II
- Regulation number
- 862.1215
- GUDID distribution status
- In Commercial Distribution
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