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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device control, white-cell
Product CodeGGL
Regulation Number 864.8625
Device Class 2


Premarket Reviews
ManufacturerDecision
STRECK
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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