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U.S. Department of Health and Human Services

Product Classification

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Device red-cell indices
Regulation Description Red cell indices device.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeKQH
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.5300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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