| Device Type ID | 4877 |
| Device Name | Sudan Iv |
| 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 | KKK |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4877 |
| Device | Sudan Iv |
| Product Code | KKK |
| 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 | Cardinal Health 200, LLC | II | Aug-21-2017 |
| 2 | Customed, Inc | I | Aug-29-2014 |