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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrument for auto reader & interpretation of overnight suscept. systems
Regulation Description Antimicrobial susceptibility test powder.
Product CodeLRG
Regulation Number 866.1640
Device Class 2


Premarket Reviews
ManufacturerDecision
FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 2
THERMO FISHER SCIENTIFIC INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Product Quality Problem 2
Incorrect, Inadequate or Imprecise Result or Readings 2
Device Handling Problem 2
Break 1
Smoking 1
Device Operates Differently Than Expected 1
Cable 1
Leak / Splash 1
Electrical Shorting 1
Pressure Problem 1
Device Emits Odor 1
Total Device Problems 14


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