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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device breast milk macronutrients test system
Definition A breast milk macronutrient test system is a device intended to quantitatively measure fat, protein, and total carbohydrate content in human breast milk. These measurements, in conjunction with other clinical assessments, may be used to aid in the nutritional management of infants.
Product CodeQEI
Regulation Number 862.1493
Device Class 2


Premarket Reviews
ManufacturerDecision
LACTATION LAB INC.
  SUBSTANTIALLY EQUIVALENT 1
MIRIS AB
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Stanbio Laboratory, LP II Apr-11-2022
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