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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

MDR Year MDR Reports MDR Events
2018 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1 1

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