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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device enzyme immunoassay, benzodiazepine
Regulation Description Benzodiazepine test system.
Product CodeJXM
Regulation Number 862.3170
Device Class 2


Premarket Reviews
ManufacturerDecision
HEALGEN SCIENTIFIC LLC
  SUBSTANTIALLY EQUIVALENT 4
IMMUNALYSIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PSYCHEMEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THERMO FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Low Test Results 9
High Test Results 3
Total Device Problems 12

Recalls
Manufacturer Recall Class Date Posted
1 Ameditech Inc III Dec-24-2015
2 Ameditech Inc II Nov-18-2015

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