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U.S. Department of Health and Human Services

Product Classification

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Device fibrin monomer paracoagulation
Regulation Description Fibrin monomer paracoagulation test.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeJBN
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type Enforcement Discretion
Regulation Number 864.7300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • In Vitro Diagnostic Fibrin Monomer Paracoagulation Test; Final [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm092798.htm] 
Third Party Review
Accredited Persons

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