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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bathophenanthroline, colorimetry, iron (non-heme)
Regulation Description Iron (non-heme) test system.
Product CodeCFM
Regulation Number 862.1410
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
KULZER
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate test results 14
Unknown (for use when the device problem is not known) 1
Total Device Problems 15

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