The following data is part of a premarket notification filed by Randox Laboratories Limited with the FDA for Direct Ldl Cholesterol (ldl).
| Device ID | K161691 |
| 510k Number | K161691 |
| Device Name: | Direct LDL Cholesterol (LDL) |
| Classification | System, Test, Low Density, Lipoprotein |
| Applicant | RANDOX LABORATORIES LIMITED 55 DIAMOND ROAD CRUMLIN Crumlin, GB Bt29 4qy |
| Contact | Pauline Armstrong |
| Correspondent | Pauline Armstong RANDOX LABORATORIES LIMITED 55 DIAMOND ROAD CRUMLIN Crumlin, GB Bt29 4qy |
| Product Code | MRR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-20 |
| Decision Date | 2017-03-20 |
| Summary: | summary |