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U.S. Department of Health and Human Services

Product Classification

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Device calibrator for hemoglobin and hematocrit measurement
Regulation Description Calibrator for hemoglobin or hematocrit measurement.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeKRZ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.8165
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
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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