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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzyme immunoassay, diphenylhydantoin
Regulation Description Diphenylhydantoin test system.
Product CodeDIP
Regulation Number 862.3350
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1

Device Problems
Incorrect or inadequate test results 9
Low test results 9
Other (for use when an appropriate device code cannot be identified) 8
Imprecision 2
Nonstandard device or device component 2
Total Device Problems 30

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories Inc. II Sep-16-2008

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