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U.S. Department of Health and Human Services

Product Classification

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Device calibrator for cell indices
Regulation Description Calibrator for cell indices.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeKRX
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.8150
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm092800.htm] 
Third Party Review
Accredited Persons

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