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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device anti-sm antibody, antigen and control
Product CodeLKP
Regulation Number 866.5100
Device Class 2


Premarket Reviews
ManufacturerDecision
INOVA DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHADIA AB
  SUBSTANTIALLY EQUIVALENT 2
PHADIA US INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Phadia Ab II Jan-28-2016
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