Ck-Mb CK1296
Ck-Mb CK1296 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 05055273201420), 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 | Number05055273201420 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK951223 | Date26 Dec 1995 | StatusActive |
Official records
- AccessGUDID record 05055273201420
- FDA 510(k) database K951223
Across registries
- FDA 510(k) K951223 decided 26 Dec 1995 Active
- FDA GUDID UDI-DI 05055273201420 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K951223
- Listed FDA GUDID 05055273201420
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- Withdrawn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
- CK1296
- Primary DI / UDI-DI
- 05055273201420
- 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).
- OLYMPUS CREATINE KINASE REAGENT OSR6179/6279 by Olympus Diagnostica GmbH
- CK-NAC REAGENT CREATINE KINASE N-ACETYL CYSTEINE by Trace Scientific, Ltd.
- CK QVET by Prisma Systems
- LIQUID-STAT LIQUID ENZYME REAGENT by Beckman Instruments, Inc.
- CREATINE KINASE (CK) by STANBIO LABORATORY
- EDC/TITAN GELISO-TOTAL CPK ISOENZYME PROCEDURE by Helena Laboratories, Corp.
- CREATINE KINASE TEST by Em Diagnostic Systems, Inc.
- ISOENZYME TEST CK-MB by Sclavo, Inc.
- BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME by Beckman Instruments, Inc.
- DYNAZYME-II TM CK-230 KIT by J.T. Baker Chemical Co.