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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device culture media, antimicrobial susceptibility test, excluding mueller hinton agar
Regulation Description Culture medium for antimicrobial susceptibility tests.
Product CodeJSO
Regulation Number 866.1700
Device Class 2


Premarket Reviews
ManufacturerDecision
BD
  SUBSTANTIALLY EQUIVALENT 4
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 4
FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 2 0 0 2 2 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 DRG International Inc II Mar-11-2010
2 Gibson Laboratories Inc II Feb-24-2010
3 Pml Microbiologicals Inc. II Oct-10-2007
4 Pml Microbiologicals Inc. II Oct-10-2007
5 Remel Inc II Aug-03-2011
6 Remel Inc II Jun-28-2011

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