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U.S. Department of Health and Human Services

Product Classification

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Device analyzer, chromosome, automated
Regulation Description Automated cell-locating device.
Regulation Medical Specialty Hematology
Review Panel Pathology
Product CodeLNJ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.5260
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Review Criteria for Assessment of Cytogenetic Analysis Using Automated and Semi-Automated Chromosome Analyzers [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094273.htm] 
Third Party Review
Accredited Persons

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