| Device Type ID | 5002 |
| Device Name | Formulations, Paraffin, All |
| Regulation Description | General Purpose Reagent. |
| Regulation Medical Specialty | Pathology |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 864.4010 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KEO |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5002 |
| Device | Formulations, Paraffin, All |
| Product Code | KEO |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | General Purpose Reagent. |
| CFR Regulation Number | 864.4010 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Sakura Finetek USA Inc | II | Jun-10-2014 |