K143691 is an FDA 510(k) clearance for the LDLC3 LDL-Cholesterol Gen.3. This device is classified as a Ldl & Vldl Precipitation, Hdl (Class I - General Controls, product code LBR).
Submitted by Roche Diagnostics Operations (Rdo) (Indianapolis, US). The FDA issued a Cleared decision on January 28, 2015, 35 days after receiving the submission on December 24, 2014.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K143691 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 2014 |
| Decision Date | January 28, 2015 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LBR — Ldl & Vldl Precipitation, Hdl |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1475 |