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U.S. Department of Health and Human Services

Product Classification

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Device cyclosporine radioimmunoassay
Regulation Description Cyclosporine test system.
Regulation Medical Specialty Clinical Chemistry
Review Panel Toxicology
Product CodeLTB
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.1235
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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