| Device Type ID | 4887 |
| Device Name | Stains, Hematology |
| Regulation Description | Dye And Chemical Solution Stains. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 864.1850 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KQC |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4887 |
| Device | Stains, Hematology |
| Product Code | KQC |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Dye And Chemical Solution Stains. |
| CFR Regulation Number | 864.1850 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Sysmex America Inc | II | Sep-09-2016 |
| 2 | Sysmex America, Inc. | II | Aug-30-2018 |
| 3 | Sysmex America, Inc. | II | Oct-16-2017 |