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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prescription use blood glucose meter for near-patient testing
Regulation Description Glucose test system.
Definition Intended for use in near-patient testing settings for in vitro diagnostic, multiple-patient use for the quantitative determination of glucose throughout all hospital and all professional healthcare settings for use in determining dysglycemia.
Product CodePZI
Regulation Number 862.1345
Device Class 2


Premarket Reviews
ManufacturerDecision
NOVA
  SUBSTANTIALLY EQUIVALENT 8
NOVA BIOMEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 8

Device Problems
Incorrect, Inadequate or Imprecise Result or Readings 2
Low Test Results 1
Device Component Or Accessory 1
Thermal Decomposition of Device 1
Total Device Problems 5


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