CALCIUM Assay 140-20
CALCIUM Assay 140-20 is a medical device (FDA Class II; FDA product code CJY, Azo Dye, Calcium) made by Sekisui Diagnostics, LLC, cleared under FDA 510(k) K895873 on 12 Dec 1989 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00628063400256), active as of 23 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 | Number00628063400256 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK895873 | Date12 Dec 1989 | StatusActive |
Official records
- AccessGUDID record 00628063400256
- FDA 510(k) database K895873
Across registries
- FDA 510(k) K895873 decided 12 Dec 1989 Active
- FDA GUDID UDI-DI 00628063400256 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K895873
- Listed FDA GUDID 00628063400256
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CALCIUM Assay
- Generic name
- Calcium (Ca2+) IVD, kit, spectrophotometry
- Model / Ref / Catalog
- 140-20
- Primary DI / UDI-DI
- 00628063400256
- 510(k) Number
- FDA product code
- CJY
- GMDN term
- Calcium (Ca2+) IVD, kit, spectrophotometry
- Device class
- Class II
- Regulation number
- 862.1145
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Calcium (Ca2+) IVD, kit, spectrophotometry.