Miris Human Milk Analyzer (HMA)
FDA 510(k) clearance K223085 · decided 2023-09-29
Clearance details
- K-number
- K223085
- Device name
- Miris Human Milk Analyzer (HMA)
- Applicant
- Miris AB
- Decision
- Substantially Equivalent
- Date received
- 2022-09-30
- Decision date
- 2023-09-29
- Days to decision
- 364 days
- Clearance type
- Traditional
- Product code
- QEI
- Device class
- 2
- Regulation number
- 862.1493
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Uppsala, SE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Emily's Care Nourish Test System (Model 1) (K234088) | Lactation Lab, Inc. | 2024-05-03 |
| Miris Human Milk Analyzer (DEN180007) | Miris AB | 2018-12-21 |
Recalls involving this device
No recalls on record reference this clearance.