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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 catalytic methods, amylase
Regulation Description Amylase test system.
Product CodeJFJ
Regulation Number 862.1070
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOSYSTEMS S.A.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
High Test Results 2
Total Device Problems 2


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