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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, specimen collection
Regulation Description Microbiological specimen collection and transport device.
Product CodeLIO
Regulation Number 866.2900
Device Class 1


Premarket Reviews
ManufacturerDecision
APEX
  SUBSTANTIALLY EQUIVALENT 1
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 2
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
HDC CORP.
  SUBSTANTIALLY EQUIVALENT 1
SAGE PRODUCTS
  SUBSTANTIALLY EQUIVALENT 3
TRINITY
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 1
Total Device Problems 1

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

Recalls
Manufacturer Recall Class Date Posted
1 Remel, Inc III Aug-18-2009

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