Test Cartridge BC4
Test Cartridge BC4 is a Class II device made by Edan Instruments, Inc., cleared under FDA 510(k) K151978 on 15 Jul 2016 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 06944413802940), 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 | Number06944413802940 | Date1 Sep 2016 | StatusListed |
| United States | FDA 510(k) | NumberK151978 | Date15 Jul 2016 | StatusActive |
Official records
- AccessGUDID record 06944413802940
- FDA 510(k) database K151978
Across registries
- FDA 510(k) K151978 decided 15 Jul 2016 Active
- FDA GUDID UDI-DI 06944413802940 listed 1 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K151978
- Listed FDA GUDID 06944413802940
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Test Cartridge
- Generic name
- Multiple blood gas analyte IVD, kit, ion-selective electrode (ISE)
- Model / reference
- BC4
- Primary DI / UDI-DI
- 06944413802940
- 510(k) Number
- FDA product code
- CHL
- GMDN term
- Multiple blood gas analyte IVD, kit, ion-selective electrode (ISE)
- Device class
- Class II
- Regulation number
- 862.1120
- GUDID distribution status
- In Commercial Distribution
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