The following data is part of a premarket notification filed by Roche Diagnostics Operations (rdo) with the FDA for Ldlc3 Ldl-cholesterol Gen.3.
| Device ID | K143691 |
| 510k Number | K143691 |
| Device Name: | LDLC3 LDL-Cholesterol Gen.3 |
| Classification | Ldl & Vldl Precipitation, Hdl |
| Applicant | Roche Diagnostics Operations (RDO) 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Noel B Mencias |
| Correspondent | Noel B Mencias Roche Diagnostics Operations (RDO) 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | LBR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-24 |
| Decision Date | 2015-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336121375 | K143691 | 000 |
| 04015630934591 | K143691 | 000 |
| 04015630934584 | K143691 | 000 |