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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bilirubin (total and unbound) in the neonate test system
Regulation Description Bilirubin (total and unbound) in the neonate test system.
Product CodeMQM
Regulation Number 862.1113
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1

Device Problems
Incorrect or inadequate test results 5
High test results 4
Low test results 2
Total Device Problems 11

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