Breast Milk Macronutrients Test System

QEI · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1493

Classification

FDA Product Code: QEI
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.1493
Review panel: CH
Medical specialty: Clinical Chemistry
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 3
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown