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510(k) K234088

Emily's Care Nourish Test System (Model 1) by Lactation Lab, Inc. — Product Code QEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2024
Date Received
December 22, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Breast Milk Macronutrients Test System
Device Class
Class II
Regulation Number
862.1493
Review Panel
CH
Submission Type

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.

Other clearances for product code QEI

  • K223085 — Miris Human Milk Analyzer (HMA) (September 29, 2023)
  • DEN180007 — Miris Human Milk Analyzer (December 21, 2018)