QEI
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Breast Milk Macronutrients Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1493
- Medical specialty
- Clinical Chemistry
- 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.
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| Record | Firm | Date |
|---|---|---|
| Emily's Care Nourish Test System (Model 1) (K234088) | Lactation Lab, Inc. | 2024-05-03 |
| Miris Human Milk Analyzer (HMA) (K223085) | Miris AB | 2023-09-29 |
| Miris Human Milk Analyzer (DEN180007) | Miris AB | 2018-12-21 |
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Every clearance here is in the API, with alerts when new ones post.