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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 Immunology
Product CodeNTH
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.4700
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems
Third Party Review Not Third Party Eligible
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