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U.S. Department of Health and Human Services

Product Classification

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Device system,test,breath nitric oxide
Regulation Description Breath nitric oxide test system.
Regulation Medical Specialty Toxicology
Review Panel Clinical Chemistry
Product CodeMXA
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.3080
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Breath Nitric Oxide Test System - Class II Special Controls Guidance Document
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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