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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzymatic method, alcohol dehydrogenase, ultraviolet
Regulation Description Alcohol test system.
Product CodeDMT
Regulation Number 862.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 1
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 1

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