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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device immunohistochemistry assay, antibody, progesterone receptor
Product CodeMXZ
Regulation Number 864.1860
Device Class 2


Premarket Reviews
ManufacturerDecision
DAKO DENMARK A/S
  SUBSTANTIALLY EQUIVALENT 1
DAKO NORTH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
LEICA BIOSYSTEMS NEWCASTLE LIMITED
  SUBSTANTIALLY EQUIVALENT 2
LEICA BIOSYSTEMS NEWCASTLE LTD.
  SUBSTANTIALLY EQUIVALENT 1
VENTANA MEDICAL SYTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Ventana Medical Systems Inc I Sep-14-2018
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