Emily's Care Nourish Test System (Model 1)
FDA 510(k) clearance K234088 · decided 2024-05-03
Clearance details
- K-number
- K234088
- Device name
- Emily's Care Nourish Test System (Model 1)
- Applicant
- Lactation Lab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-12-22
- Decision date
- 2024-05-03
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- QEI
- Device class
- 2
- Regulation number
- 862.1493
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Manhattan Beach, CA, US
- 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 |
|---|---|---|
| Miris Human Milk Analyzer (HMA) (K223085) | Miris AB | 2023-09-29 |
| Miris Human Milk Analyzer (DEN180007) | Miris AB | 2018-12-21 |
Recalls involving this device
No recalls on record reference this clearance.