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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device radioimmunoassay, total thyroxine
Regulation Description Total thyroxine test system.
Product CodeCDX
Regulation Number 862.1700
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 6
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 4
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 2
  1.  K800203  RIA PHASE T4
  2.  K961490  ELECSYS T4 ASSAY
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 4
DOW
  SUBSTANTIALLY EQUIVALENT 1
KULZER
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
High test results 6
Incorrect or inadequate test results 2
Low test results 1
Total Device Problems 9

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