510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QEIClass II

Breast Milk Macronutrients Test System

21 CFR 862.1493 / Clinical Chemistry
FDA source (opens on fda.gov)

QEI is the FDA product code for Breast Milk Macronutrients Test System, a class II device type, regulated under 21 CFR 862.1493. FDA's definition for this code reads: "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". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
QEI
Device name
Breast Milk Macronutrients Test System
FDA 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.
Regulation
21 CFR 862.1493
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
1

Clearances, product code QEI

By decision year
3 clearances under product code QEI with a decision year between 2018 and 2024, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QEI by decision year
YearClearances
20181
20231
20241

Applicants with the most clearances

Product code QEI
Applicants holding the most 510(k) clearances under product code QEI
ApplicantClearances
Miris AB2
Lactation Lab, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code