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U.S. Department of Health and Human Services

Product Classification
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Device test,natriuretic peptide
Regulation Description B-type natriuretic peptide test system.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeNBC
Submission Type 510(k)
Regulation Number 862.1117
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm092787.htm] 
Third Party Review Not Third Party Eligible
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