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U.S. Department of Health and Human Services

Product Classification
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Device fluroesence polorization immunoassay for cyclosporine
Regulation Description Cyclosporine test system.
Regulation Medical Specialty Clinical Chemistry
Review Panel Toxicology
Product CodeMGU
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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