Cardiac Marker Control 150-2
Cardiac Marker Control 150-2 is a Class I device made by More Diagnostics Inc, cleared under FDA 510(k) K972976 on 29 Aug 1997 and listed in FDA GUDID since 31 Mar 2018 (UDI-DI 00856743007031), 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 | Number00856743007031 | Date31 Mar 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK972976 | Date29 Aug 1997 | StatusActive |
Official records
- AccessGUDID record 00856743007031
- FDA 510(k) database K972976
Across registries
- FDA 510(k) K972976 decided 29 Aug 1997 Active
- FDA GUDID UDI-DI 00856743007031 listed 31 Mar 2018 Listed
Timeline
- Cleared FDA 510(k) K972976
- Listed FDA GUDID 00856743007031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cardiac Marker Control
- Generic name
- Multiple cardiac marker IVD, control
- Model / Ref / Catalog
- 150-2
- Primary DI / UDI-DI
- 00856743007031
- 510(k) Number
- FDA product code
- JJT
- GMDN term
- Multiple cardiac marker IVD, control
- Device class
- Class I
- Regulation number
- 862.1660
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Multiple cardiac marker IVD, control.
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- Cardiac Control Complete +TnT level 3 91492 by Cliniqa Corporation
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- Triage 88754 by Quidel Cardiovascular Inc.
- Triage 88733 by Quidel Cardiovascular Inc.
- RAMP® Cardiac Controls - Level 1 C5003-1 by Response Biomedical Corp