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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device test, cystatin c
Regulation Description Creatinine test system.
Product CodeNDY
Regulation Number 862.1225
Device Class 2


Premarket Reviews
ManufacturerDecision
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 3
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
High test results 2
Total Device Problems 2

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