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U.S. Department of Health and Human Services

Product Classification

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Device abnormal hemoglobin quantitation
Regulation Description Abnormal hemoglobin assay.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeGKA
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.7415
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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