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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device labware, assisted reproduction
Regulation Description Assisted reproduction labware.
Product CodeMQK
Regulation Number 884.6160
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLWIN MEDICAL DEVICES, INC
  SUBSTANTIALLY EQUIVALENT 1
DXNOW, INC.
  SUBSTANTIALLY EQUIVALENT 1
HERTART APS
  SUBSTANTIALLY EQUIVALENT 1
KITAZATO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORIGIO A/S
  SUBSTANTIALLY EQUIVALENT 3
REPROBITECH CORP.
  SUBSTANTIALLY EQUIVALENT 2
VITROLIFE SWEDEN AB
  SUBSTANTIALLY EQUIVALENT 1

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