CardioChek 5700415
CardioChek 5700415 is a Class II device made by Henry Schein, Inc., cleared under FDA 510(k) K140068 on 22 May 2015 and listed in FDA GUDID since 5 Jan 2017 (UDI-DI 10304040037727), active as of 23 Oct 2026. 4 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10304040037727 | Date5 Jan 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140068 | Date22 May 2015 | StatusActive |
Official records
- AccessGUDID record 10304040037727
- FDA 510(k) database K140068
Across registries
- FDA 510(k) K140068 decided 22 May 2015 Active
- FDA GUDID UDI-DI 10304040037727 listed 5 Jan 2017 Listed
Recalls
-
- Terminated Z-0833-2020
- Terminated Z-0835-2020
- Terminated Z-0834-2020
- Terminated Z-0832-2020
One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.
Timeline
- Cleared FDA 510(k) K140068
- Listed FDA GUDID 10304040037727
- Recall initiated FDA recalls Z-0833-2020
- Recall initiated FDA recalls Z-0835-2020
- Recall initiated FDA recalls Z-0834-2020
- Recall initiated FDA recalls Z-0832-2020
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CardioChek
- Generic name
- Multiple lipid analyte IVD, kit, multiple technologies
- Model / Ref / Catalog
- 5700415
- Primary DI / UDI-DI
- 10304040037727
- 510(k) Number
- FDA product code
- CGA, NBW
- GMDN term
- Multiple lipid analyte IVD, kit, multiple technologies
- Device class
- Class II
- Regulation number
- 862.1345
- GUDID distribution status
- In Commercial Distribution
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