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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device radioimmunoassay, gentamicin (125-i), second antibody sep.
Regulation Description Gentamicin test system.
Product CodeDJB
Regulation Number 862.3450
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 2
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 3
Nichols Institute Diagnostics
  SUBSTANTIALLY EQUIVALENT 1

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