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U.S. Department of Health and Human Services

Product Classification
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Device radioimmunoassay, netilmicin (i-125)
Regulation Description Gentamicin test system.
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeLCE
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.3450
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
Third Party Review Not Third Party Eligible
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