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U.S. Department of Health and Human Services

Product Classification
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Device hemoglobin a1c test system
Regulation Description Hemoglobin A1c test system.
Definition Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.
Physical State In-Vitro Diagnostic Reagent Kit
Technical Method Assay detecting glycated hemoglobin
Target Area Whole blood
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodePDJ
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.1373
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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