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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device chromatographic/fluorometric method, catecholamines
Regulation Description Catecholamines (total) test system.
Product CodeCHQ
Regulation Number 862.1165
Device Class 1


Premarket Reviews
ManufacturerDecision
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 2
ESA, INC.
  SUBSTANTIALLY EQUIVALENT 3

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