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U.S. Department of Health and Human Services

Product Classification

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Device enzymatic radiochemical assay, tobramycin
Regulation Description Tobramycin test system.
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeLDO
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.3900
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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