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U.S. Department of Health and Human Services

Product Classification

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Device flame photometry, lithium
Regulation Description Lithium test system.
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeJIH
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.3560
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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