Tissue Processing Kit
Device Code: 5046
Product Code(s):
PFU Definition: For The Preparation Of Human Tissue Specimens For Frozen Sectioning And Histological Examination.
Device Classification Information
| Device Type ID | 5046 |
| Device Name | Tissue Processing Kit |
| Physical State | Freezing Device, Heat Sink And A Chuck With Embeddign Mold |
| Technical Method | The Freezing Device And Heat Sink Are Housed In An Insulated Box And The Entire Kit Would Be Used At The Dissecting Bench, Allowing Users To Freeze The Sample For Future Cutting Or Slicing. |
| Target Area | Any Human Tissue |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | Enforcement Discretion |
| FDA Device Classification | Class Not Classified Medical Device |
| Product Code | PFU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 5046 |
| Device | Tissue Processing Kit |
| Product Code | PFU |
TPLC Last Update: 2019-04-02 20:59:19