FDA Product Code QEI: Breast Milk Macronutrients Test System
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.
Leading manufacturers include Miris AB and Lactation Lab, Inc..
FDA 510(k) Cleared Breast Milk Macronutrients Test System Devices (Product Code QEI)
About Product Code QEI - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QEI since 2018, with 2 receiving FDA clearance (average review time: 270 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
QEI devices are reviewed by the Chemistry panel. Browse all Chemistry devices →