510(k) K234088
K234088 is an FDA 510(k) premarket notification submitted by Lactation Lab, Inc. for the device "Emily's Care Nourish Test System (Model 1)". The FDA issued a decision of Substantially Equivalent on May 3, 2024. The device falls under product code QEI (Breast Milk Macronutrients Test System), a Class II device regulated under 21 CFR 862.1493.
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.