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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
AUXOGYN, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
HERTART
  SUBSTANTIALLY EQUIVALENT 1
KITAZATO BIOPHARMA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
KITAZATO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MENICON CO., LTD. NEW BUSINESS DIVISION
  SUBSTANTIALLY EQUIVALENT 1
NIDACON INTERNATIONAL AB
  SUBSTANTIALLY EQUIVALENT 1
ORIGIO A/S
  SUBSTANTIALLY EQUIVALENT 2
REPROLIFE INC.
  SUBSTANTIALLY EQUIVALENT 1
VITROLIFE A/S
  SUBSTANTIALLY EQUIVALENT 1
VITROLIFE AB
  SUBSTANTIALLY EQUIVALENT 2
VITROLIFE, INC.
  SUBSTANTIALLY EQUIVALENT 2

Recalls
Manufacturer Recall Class Date Posted
1 ORIGIO, Inc II Jun-30-2014

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