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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device c-reactive protein, antigen, antiserum, and control
Product CodeDCK
Regulation Number 866.5270
Device Class 2


Premarket Reviews
ManufacturerDecision
HORIBA ABX SAS
  SUBSTANTIALLY EQUIVALENT 2
PROCISE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SENTINEL CH, SPA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 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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