The following data is part of a premarket notification filed by Randox Laboratories Ltd. with the FDA for Randox Calcium (ca).
| Device ID | K182042 |
| 510k Number | K182042 |
| Device Name: | Randox Calcium (Ca) |
| Classification | Azo Dye, Calcium |
| Applicant | Randox Laboratories Ltd. 55 Diamond Road Crumlin, GB Bt29 4qy |
| Contact | Pauline Armstrong |
| Correspondent | Pauline Armstrong Randox Laboratories Ltd. 55 Diamond Road Crumlin, GB Bt29 4qy |
| Product Code | CJY |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-30 |
| Decision Date | 2018-10-23 |
| Summary: | summary |