510(k) DEN180007

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

December 21, 2018

Date Received

February 12, 2018

Clearance Type

Direct

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.