K000568 is an FDA 510(k) clearance for the HDL CHOLESTEROL PLUS. This device is classified as a Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl (Class I - General Controls, product code LBT).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 4, 2000, 164 days after receiving the submission on February 22, 2000.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K000568 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 2000 |
| Decision Date | August 04, 2000 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LBT — Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1475 |