The following data is part of a premarket notification filed by Randox Laboratories Ltd with the FDA for Randox Rx Daytona Plus Magnesium (mg).
| Device ID | K162200 |
| 510k Number | K162200 |
| Device Name: | Randox RX Daytona Plus Magnesium (MG) |
| Classification | Photometric Method, Magnesium |
| Applicant | RANDOX LABORATORIES LTD 55 DIAMOND ROAD Crumlin, GB Bt29 4qy |
| Contact | Pauline 0 Armstrong |
| Correspondent | Pauline 0 Armstrong RANDOX LABORATORIES LTD 55 DIAMOND ROAD Crumlin, GB Bt29 4qy |
| Product Code | JGJ |
| CFR Regulation Number | 862.1495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-05 |
| Decision Date | 2017-04-28 |
| Summary: | summary |