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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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.
Product CodePDJ
Regulation Number 862.1373
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS CORP.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

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