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U.S. Department of Health and Human Services

Product Classification

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Device kit, disc, agar gel diffusion, determine serum levels of gentamicin
Regulation Description Gentamicin test system.
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeKZT
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.3450
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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