K234088 is an FDA 510(k) clearance for the Emily's Care Nourish Test System (Model 1). This device is classified as a Breast Milk Macronutrients Test System (Class II - Special Controls, product code QEI).
Submitted by Lactation Lab, Inc. (Manhattan Beach, US). The FDA issued a Cleared decision on May 3, 2024, 133 days after receiving the submission on December 22, 2023.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1493. 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..
| 510(k) Number | K234088 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2023 |
| Decision Date | May 03, 2024 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | QEI - Breast Milk Macronutrients Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1493 |
| 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. |