Panels › Clinical Chemistry › Product code QEI · Class 2
Breast Milk Macronutrients Test System
Regulation 862.1493
0510(k)s in 12 months (3 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in QEI
| Company | 510(k)s | Recalls |
|---|---|---|
| Miris AB | 2 | 0 |
| Lactation Lab, Inc. | 1 | 0 |
| Stanbio Laboratory, LP | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 3, 2024 | K234088 | Emily's Care Nourish Test System (Model 1) Lactation Lab, Inc. | QEI |
| Sep 29, 2023 | K223085 | Miris Human Milk Analyzer (HMA) Miris AB, SE | QEI |
| Dec 21, 2018 | DEN180007 | Miris Human Milk Analyzer Miris AB, SE | QEI |
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