K150654 is an FDA 510(k) clearance for the Cholesterol. This device is classified as a Enzymatic Esterase--oxidase, Cholesterol (Class I - General Controls, product code CHH).
Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on September 29, 2015, 200 days after receiving the submission on March 13, 2015.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1175.
| 510(k) Number | K150654 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 13, 2015 |
| Decision Date | September 29, 2015 |
| Days to Decision | 200 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CHH — Enzymatic Esterase--oxidase, Cholesterol |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1175 |