| Device Type ID | 2347 |
| Device Name | Lymphocyte Separation Medium |
| Regulation Description | Lymphocyte Separation Medium. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 864.8500 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JCF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2347 |
| Device | Lymphocyte Separation Medium |
| Product Code | JCF |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Lymphocyte Separation Medium. |
| CFR Regulation Number | 864.8500 [🔎] |
| Device Problems | |
|---|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 28 |
Incorrect Or Inadequate Test Results | 5 |
Break | 4 |
Leak / Splash | 3 |
Device Contamination With Chemical Or Other Material | 2 |
Material Deformation | 1 |
Volume Accuracy Problem | 1 |
| Total Device Problems | 44 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Becton Dickinson & Company | II | Aug-22-2014 |