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U.S. Department of Health and Human Services

Product Classification
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Device microscope, automated, image analysis, operator intervention
Regulation Description Immunohistochemistry reagents and kits.
Definition Automated microscopic immunohistochemistry image-analysis system to measure cell membrane intensity and pattern with operator intervention.
Regulation Medical Specialty Hematology
Review Panel Pathology
Product CodeNOT
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
Third Party Review Not Third Party Eligible
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