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 Nu
| Device Type ID | 686 |
| Device Name | Breast Milk Macronutrients Test System |
| Physical State | In Vitro Diagnostic Device |
| Technical Method | Quantitative, Mid-infrared Spectroscopy |
| Target Area | Human Breast Milk |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1493 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QEI |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 686 |
| Device | Breast Milk Macronutrients Test System |
| Product Code | QEI |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 862.1493 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MIRIS AB | ||
GRANTED | 1 | |