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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
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
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 Standard
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  • Draft Guidance Document for 510(k) Submission of Glycohemoglobin (Glycated or Glycosylated) Hemoglobin for IVDs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] 
Third Party Review
Accredited Persons

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