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U.S. Department of Health and Human Services

Product Classification

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Device glucose-6-phosphate dehydrogenase (erythrocytic), u.v. kinetic
Regulation Description Erythrocytic glucose-6-phosphate dehydrogenase assay.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeJBK
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.7360
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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