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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device urease, photometric, urea nitrogen
Product CodeCDN
Regulation Number 862.1770
Device Class 2


Premarket Reviews
ManufacturerDecision
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
HITACHI CHEMICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Or Inadequate Test Results 1 1
Fluid/Blood Leak 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Ortho-Clinical Diagnostics II Nov-15-2013
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