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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device control, hemoglobin
Regulation Description Hematology quality control mixture.
Product CodeGGM
Regulation Number 864.8625
Device Class 2


Premarket Reviews
ManufacturerDecision
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 3
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device handling issue 1
Total Device Problems 1

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