Device |
microscope, automated, image analysis, immunohistochemistry,operator intervention,nuclear intensity & percent positivity |
Regulation Description |
Immunohistochemistry reagents and kits. |
Definition |
Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention. |
Regulation Medical Specialty |
Hematology |
Review Panel |
Pathology |
Product Code | NQN |
Premarket Review |
Division of Molecular Genetics and Pathology
(DMGP)
Division of Molecular Genetics and Pathology
(DMGP)
|
Submission Type |
510(k)
|
Regulation Number |
864.1860
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standard
|
Third Party Review |
Not Third Party Eligible |