| Device Type ID | 4959 |
| Device Name | Cassettes, Tissue |
| Regulation Description | Tissue Processing Equipment. |
| 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 | 864.3010 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | IDZ |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4959 |
| Device | Cassettes, Tissue |
| Product Code | IDZ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Tissue Processing Equipment. |
| CFR Regulation Number | 864.3010 [🔎] |
| Device Problems | |
|---|---|
Improper Or Incorrect Procedure Or Method | 3 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Use Of Device Problem | 1 |
Device Issue | 1 |
Human Factors Issue | 1 |
| Total Device Problems | 7 |