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U.S. Department of Health and Human Services

Product Classification

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Device fluorometric, cortisol
Regulation Description Cortisol (hydrocortisone and hydroxycorticosterone) test system.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeJFT
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.1205
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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