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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
Premarket Review Office of In Vitro Diagnostics (OHT7)
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
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