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U.S. Department of Health and Human Services

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Device calibrator for red-cell and white-cell counting
Regulation Description Calibrator for red cell and white cell counting.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeKSA
Submission Type 510(k)
Regulation Number 864.8185
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] 
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