DEN180007 is an FDA 510(k) submission for the Miris Human Milk Analyzer. This device is classified as a Breast Milk Macronutrients Test System (Class II - Special Controls, product code QEI).
Submitted by Miris AB (Uppsala, SE). The FDA issued a Not Cleared (DENG) decision on December 21, 2018.
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 | DEN180007 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | February 12, 2018 |
| Decision Date | December 21, 2018 |
| Days to Decision | 312 days |
| Submission Type | Direct |
| Review Panel | Chemistry (CH) |
| Summary | - |
| 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. |