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U.S. Department of Health and Human Services

Product Classification
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Device assay, glycosylated hemoglobin
Regulation Description Glycosylated hemoglobin assay.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeLCP
Submission Type 510(k)
Regulation Number 864.7470
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Draft Guidance Document for 510(k) Submission of Glycohemoglobin (Glycated or Glycosylated) Hemoglobin for IVDs [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094266.htm] 
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