| Device Type ID | 599 |
| Device Name | Ldl & Vldl Precipitation, Hdl |
| Regulation Description | Lipoprotein Test System. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.1475 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | LBR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 599 |
| Device | Ldl & Vldl Precipitation, Hdl |
| Product Code | LBR |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Lipoprotein Test System. |
| CFR Regulation Number | 862.1475 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ROCHE DIAGNOSTICS OPERATIONS (RDO) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Low Test Results | 1 |
High Test Results | 1 |
| Total Device Problems | 2 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Medtest Holdings, Inc. | III | Nov-05-2018 |
| 2 | Pointe Scientific, Inc. | III | Sep-14-2015 |
| 3 | Roche Diagnostics Operations, Inc. | II | Jun-27-2015 |
| 4 | Sterling Diagnostics, Inc. | III | Dec-29-2016 |