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U.S. Department of Health and Human Services

Product Classification
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Device test, glycosylated hemoglobin, over the counter
Regulation Description Glycosylated hemoglobin assay.
Regulation Medical Specialty Hematology
Review Panel Toxicology
Product CodeNGB
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 864.7470
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 Not Third Party Eligible
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