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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device radioassay, triiodothyronine uptake
Regulation Description Triiodothyronine uptake test system.
Product CodeKHQ
Regulation Number 862.1715
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 2
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
DOW
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
Nichols Institute Diagnostics
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
TOSOH CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
High test results 1
Total Device Problems 1

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