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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
Submission Type 510(k)
Regulation Number 862.1510
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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