K161691 is an FDA 510(k) clearance for the Direct LDL Cholesterol (LDL). This device is classified as a System, Test, Low Density, Lipoprotein (Class I - General Controls, product code MRR).
Submitted by Randox Laboratories Limited (Crumlin, GB). The FDA issued a Cleared decision on March 20, 2017, 273 days after receiving the submission on June 20, 2016.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K161691 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2016 |
| Decision Date | March 20, 2017 |
| Days to Decision | 273 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | MRR - System, Test, Low Density, Lipoprotein |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1475 |