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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device system, automated platelet aggregation
Regulation Description Automated platelet aggregation system.
Product CodeJOZ
Regulation Number 864.5700
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCRIVA DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
AGGREDYNE, INC.
  SUBSTANTIALLY EQUIVALENT 2
CHRONO-LOG CORP.
  SUBSTANTIALLY EQUIVALENT 1
CORAMED TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
High Test Results 25
Low Test Results 5
Incorrect, Inadequate or Imprecise Resultor Readings 4
Insufficient Information 1
Non Reproducible Results 1
Adverse Event Without Identified Device or Use Problem 1
Total Device Problems 37


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