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U.S. Department of Health and Human Services

Product Classification

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Device myoglobin, antigen, antiserum, control
Regulation Description Myoglobin immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeDDR
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5680
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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