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U.S. Department of Health and Human Services

Product Classification
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Device system, analysis, electrophoretic hemoglobin
Regulation Description Electrophoretic hemoglobin analysis system.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeJBD
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 864.7440
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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