Definition: Automated Microscopic Immunohistochemistry Image-analysis System To Measure Cell Membrane Intensity And Pattern With Operator Intervention.
| Device Type ID | 4899 |
| Device Name | Microscope, Automated, Image Analysis, Operator Intervention |
| Regulation Description | Immunohistochemistry Reagents And Kits. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.1860 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NOT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4899 |
| Device | Microscope, Automated, Image Analysis, Operator Intervention |
| Product Code | NOT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Immunohistochemistry Reagents And Kits. |
| CFR Regulation Number | 864.1860 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
APERIO TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Computer Software Problem | 1 |
Incorrect Software Programming Calculations | 1 |
| Total Device Problems | 2 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Leica Biosystems Imaging, Inc. | II | Mar-07-2014 |