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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device autoantibodies, lkm-1 (liver/kidney microsome, type 1)
Product CodeNBS
Regulation Number 866.5660
Device Class 2


Premarket Reviews
ManufacturerDecision
EUROIMMUN US
  SUBSTANTIALLY EQUIVALENT 1
INOVA DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

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