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U.S. Department of Health and Human Services

Product Classification
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Device system, automated scanning microscope and image analysis for fluorescence in situ hybridization (fish) assays
Regulation Description Automated fluorescence in situ hybridization (FISH) enumeration systems.
Regulation Medical Specialty Immunology
Review Panel Pathology
Product CodeNTH
Premarket Review Division of Molecular Genetics and Pathology (DMGP)
Division of Molecular Genetics and Pathology (DMGP)
Submission Type 510(k)
Regulation Number 866.4700
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
Guidance Document
Third Party Review Not Third Party Eligible
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