K012286 is an FDA 510(k) clearance for the MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION. This device is classified as a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I - General Controls, product code LBS).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 8, 2001, 19 days after receiving the submission on July 20, 2001.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K012286 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 2001 |
| Decision Date | August 08, 2001 |
| Days to Decision | 19 days |
| Submission Type | Special |
| 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 |