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U.S. Department of Health and Human Services

Product Classification
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Device test, nitrite, urinary, non-quantitative, over the counter
Regulation Description Nitrite (nonquantitative) test system.
Regulation Medical Specialty Clinical Chemistry
Review Panel Toxicology
Product CodeNGJ
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.1510
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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