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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, thyroxine-binding globulin
Regulation Description Thyroxine-binding globulin test system.
Product CodeCEE
Regulation Number 862.1685
Device Class 2


Premarket Reviews
ManufacturerDecision
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 3
Nichols Institute Diagnostics
  SUBSTANTIALLY EQUIVALENT 1

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