Miris Human Milk Analyzer
FDA 510(k) clearance DEN180007 · decided 2018-12-21
Clearance details
- K-number
- DEN180007
- Device name
- Miris Human Milk Analyzer
- Applicant
- Miris AB
- Decision
- Unknown
- Date received
- 2018-02-12
- Decision date
- 2018-12-21
- Days to decision
- 312 days
- Clearance type
- Direct
- 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 (HMA) (K223085) | Miris AB | 2023-09-29 |
Recalls involving this device
No recalls on record reference this clearance.