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U.S. Department of Health and Human Services

Product Classification

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Device enzyme controls (assayed and unassayed)
Regulation Description Quality control material (assayed and unassayed).
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeJJT
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.1660
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review
Accredited Persons

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