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U.S. Department of Health and Human Services

Product Classification
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Device glucose-6-phosphate dehydrogenase (erythrocytic), spot
Regulation Description Erythrocytic glucose-6-phosphate dehydrogenase assay.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeJBG
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 864.7360
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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