The following data is part of a premarket notification filed by Randox Laboratories Limited with the FDA for Triglycerides.
| Device ID | K150819 |
| 510k Number | K150819 |
| Device Name: | Triglycerides |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | Randox Laboratories Limited 55 Diamond Road Crumlin, GB Bt29 4qy |
| Contact | Pauline Armstrong |
| Correspondent | Pauline Armstrong Randox Laboratories Limited 55 Diamond Road Crumlin, GB Bt29 4qy |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-27 |
| Decision Date | 2015-08-06 |
| Summary: | summary |