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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
EUROTROL B.V.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Human-Device Interface Problem 1
Total Device Problems 1

Recalls
Manufacturer Recall Class Date Posted
1 EUROTROL INC II Nov-28-2018

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