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U.S. Department of Health and Human Services

Product Classification

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Device reagent, occult blood
Regulation Description Occult blood test.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeKHE
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.6550
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and FDA Staff - Review Criteria for Assessment of Qualitative Fecal Occult Blood In Vitro Diagnostic Devices [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm079181.htm] 
Third Party Review
Accredited Persons

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