| Device Type ID | 688 |
| Device Name | Kit, Assay, Progesterone Receptor |
| Regulation Description | Immunohistochemistry Reagents And Kits. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | PMA |
| CFR Regulation Number | 864.1860 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | LPI |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 688 |
| Device | Kit, Assay, Progesterone Receptor |
| Product Code | LPI |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Immunohistochemistry Reagents And Kits. |
| CFR Regulation Number | 864.1860 [🔎] |