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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device blood, occult, colorimetric, in urine
Product CodeJIO
Regulation Number 864.6550
Device Class 2


Premarket Reviews
ManufacturerDecision
ACON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEALGEN SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 1
URIT MEDICAL ELECTRONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WIENER LABORATORIOS S.A.I.C.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 3 3
False Positive Result 1 1
Incorrect Or Inadequate Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4 4
No Consequences Or Impact To Patient 1 1

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