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U.S. Department of Health and Human Services

Product Classification

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Device radioimmunoassay, conjugated sulfalithocholic (slcg) acid, bile acids
Regulation Description Conjugated sulfolithocholic acid (SLCG) test system.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeKWX
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.1187
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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