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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 (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.3080
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Guidance Document
Third Party Review Not Third Party Eligible
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