The following data is part of a premarket notification filed by Randox Laboratories Limited with the FDA for Randox Rx Daytona Plus Alkaline Phosphatase (alp).
| Device ID | K162275 |
| 510k Number | K162275 |
| Device Name: | Randox RX Daytona Plus Alkaline Phosphatase (ALP) |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Applicant | RANDOX LABORATORIES LIMITED 55 DIAMOND ROAD Crumlin, County Antrim, GB Bt29 4qy |
| Contact | Pauline Armstrong |
| Correspondent | Pauline Armstrong RANDOX LABORATORIES LIMITED 55 DIAMOND ROAD Crumlin, County Antrim, GB Bt29 4qy |
| Product Code | CJE |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-12 |
| Decision Date | 2017-04-21 |
| Summary: | summary |