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U.S. Department of Health and Human Services

Product Classification
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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 CodeNQN
Submission Type 510(k)
Regulation Number 864.1860
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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