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U.S. Department of Health and Human Services

Product Classification

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Device fluorometric method, cpk or isoenzymes
Regulation Description Creatine phosphokinase/creatine kinase or isoenzymes test system.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeJHX
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.1215
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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