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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device turbidimetric method, protein or albumin (urinary, non-quant.)
Product CodeJIQ
Regulation Number 862.1645
Device Class 1


Premarket Reviews
ManufacturerDecision
ROCHE DIAGNOSTICS OPERATIONS (RDO)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 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

Recalls
Manufacturer Recall Class Date Posted
1 HemoCue AB III Dec-28-2012
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