| Device Type ID | 2279 |
| Device Name | Diluent, Blood Cell |
| Regulation Description | Blood Cell Diluent. |
| 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 | 864.8200 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GIF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2279 |
| Device | Diluent, Blood Cell |
| Product Code | GIF |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Blood Cell Diluent. |
| CFR Regulation Number | 864.8200 [🔎] |
| Device Problems | |
|---|---|
Device Ingredient Or Reagent Problem | 7 |
| Total Device Problems | 7 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Beckman Coulter Inc. | II | Aug-28-2015 |
| 2 | Beckman Coulter Inc. | II | May-15-2015 |
| 3 | Beckman Coulter Inc. | II | Sep-16-2014 |
| 4 | Mindray DS USA, Inc. Dba Mindray North America | II | Apr-09-2018 |