K153435 is an FDA 510(k) clearance for the Direct HDL Cholesterol (HDL). This device is classified as a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I - General Controls, product code LBS).
Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on January 8, 2016, 42 days after receiving the submission on November 27, 2015.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K153435 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 2015 |
| Decision Date | January 08, 2016 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LBS — Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1475 |