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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device manual antimicrobial susceptibility test systems
Regulation Description Antimicrobial susceptibility test powder.
Product CodeJWY
Regulation Number 866.1640
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 7
BD
  SUBSTANTIALLY EQUIVALENT 6
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
DADE
  SUBSTANTIALLY EQUIVALENT 20
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 6
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 4
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 4
MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROTEK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
SIEMENS
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
Trek Diagnostic Systems
  SUBSTANTIALLY EQUIVALENT 25
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 21

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

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc. II May-08-2012
2 Siemens Microscan II Feb-04-2009

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