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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device immunoglobulin g kappa heavy and light chain combined
Definition Intended for the in-vitro quantification of IgG kappa concentration in human serum.
Product CodePCN
Regulation Number 866.5510
Device Class 2


Premarket Reviews
ManufacturerDecision
THE BINDING SITE
  SUBSTANTIALLY EQUIVALENT 1
THE BINDING SITE GROUP LTD
  SUBSTANTIALLY EQUIVALENT 1
THE BINDING SITE GROUP LTD.
  SUBSTANTIALLY EQUIVALENT 1

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