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U.S. Department of Health and Human Services

Product Classification

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Device hemoglobinometer
Regulation Description Whole blood hemoglobin assays.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeGIG
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.7500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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