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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device panels, test, susceptibility, antimicrobial
Regulation Description Antimicrobial susceptibility test powder.
Product CodeLTT
Regulation Number 866.1640
Device Class 2


Premarket Reviews
ManufacturerDecision
DADE
  SUBSTANTIALLY EQUIVALENT 9
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 3
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
Trek Diagnostic Systems
  SUBSTANTIALLY EQUIVALENT 4

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 2
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc. II Jun-08-2013
2 Siemens Healthcare Diagnostics, Inc. II May-08-2013

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