Ck-Mb CK1553
Ck-Mb CK1553 is a Class II device made by Randox Laboratories, Ltd., cleared under FDA 510(k) K951223 on 26 Dec 1995 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 05055273201444), 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 | Number05055273201444 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK951223 | Date26 Dec 1995 | StatusActive |
Official records
- AccessGUDID record 05055273201444
- FDA 510(k) database K951223
Across registries
- FDA 510(k) K951223 decided 26 Dec 1995 Active
- FDA GUDID UDI-DI 05055273201444 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K951223
- Listed FDA GUDID 05055273201444
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- Withdrawn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
- CK1553
- Primary DI / UDI-DI
- 05055273201444
- 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
Similar devices
Other devices filed under FDA product code CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes).
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- TITAN GEL REP CPK-12 HV by Helena Laboratories, Corp.
- ADVIA Chemistry Creatine Kinase 10729780 by Siemens Healthcare Diagnostics Inc.
- ATAC PAK CPK REAGENT KIT by Elan Holdings, Inc.
- HICHEM CK/NAC REAGENT KIT by Elan Pharma, Inc.
- IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE) by Intl. Immunoassay Laboratories, Inc.
- CREATINE KINASE (CK) REAGENT SET by POINTE SCIENTIFIC, INC.
- OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 by Olympus America, Inc.