Ca CA590
Ca CA590 is a medical device (FDA Class II; FDA product code CIC, Cresolphthalein Complexone, Calcium) made by Randox Laboratories, Ltd., cleared under FDA 510(k) K000375 on 5 Apr 2000 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 05055273200911), 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 | Number05055273200911 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK000375 | Date5 Apr 2000 | StatusActive |
Official records
- AccessGUDID record 05055273200911
- FDA 510(k) database K000375
Across registries
- FDA 510(k) K000375 decided 5 Apr 2000 Active
- FDA GUDID UDI-DI 05055273200911 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K000375
- Listed FDA GUDID 05055273200911
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ca
- Generic name
- Calcium (Ca2+) IVD, reagent
- Model / Ref / Catalog
- CA590
- Primary DI / UDI-DI
- 05055273200911
- 510(k) Number
- FDA product code
- CIC
- GMDN term
- Calcium (Ca2+) IVD, reagent
- Device class
- Class II
- Regulation number
- 862.1145
- GUDID distribution status
- In Commercial Distribution
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