The following data is part of a premarket notification filed by Roche Diagnostics Operations (rdo) with the FDA for Hdl-cholesterol Gen.4.
| Device ID | K162593 |
| 510k Number | K162593 |
| Device Name: | HDL-Cholesterol Gen.4 |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | Roche Diagnostics Operations (RDO) 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Barbara Mcwhorter |
| Correspondent | Barbara Mcwhorter Roche Diagnostics Operations (RDO) 9115 Hague Road SUITE 114 Indianapolis, IN 46250 |
| Product Code | LBS |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-16 |
| Decision Date | 2016-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336121306 | K162593 | 000 |
| 04015630942589 | K162593 | 000 |
| 04015630942572 | K162593 | 000 |
| 04015630942565 | K162593 | 000 |