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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
BIOGENEX
  SUBSTANTIALLY EQUIVALENT 1
MID-ATLANTIC DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NONE
  SUBSTANTIALLY EQUIVALENT 2
NUNC A/S
  SUBSTANTIALLY EQUIVALENT 2
RESEARCH INSTRUMENTS LTD.
  SUBSTANTIALLY EQUIVALENT 1
VITROLIFE, INC.
  SUBSTANTIALLY EQUIVALENT 2

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 1 0 0 0 0 1 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Humagen Fertility Diagnostics, Inc. II Sep-18-2007
2 ORIGIO HUMAGEN PIPETS INC. II Feb-23-2012
3 ORIGIO, Inc II Jun-30-2014

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