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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, hemoglobin, automated
Regulation Description Automated hemoglobin system.
Product CodeGKR
Regulation Number 864.5620
Device Class 2


Premarket Reviews
ManufacturerDecision
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL TECHNIDYNE CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYSMEX
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
High test results 3
Measurements, inaccurate 2
Incorrect or inadequate result 2
Device Issue 1
Incorrect or inadequate test results 1
Low test results 1
Output issue 1
Device handling issue 1
Total Device Problems 12

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