K100010 is an FDA 510(k) clearance for the HDL CHOLESTEROL (HDLX) ASSAY. This device is classified as a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I - General Controls, product code LBS).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on May 14, 2010, 130 days after receiving the submission on January 4, 2010.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K100010 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 04, 2010 |
| Decision Date | May 14, 2010 |
| Days to Decision | 130 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 |