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510(k) Data Aggregation
K Number
K234088Device Name
Emily's Care Nourish Test System (Model 1)
Manufacturer
Date Cleared
2024-05-03
(133 days)
Product Code
Regulation Number
862.1493Why did this record match?
Applicant Name (Manufacturer) :
Lactation Lab Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Emily's Care Nourish Test System (Model 1) quantitatively measures the concentration of protein, fat (triglycerides), and carbohydrates (lactose) in human milk. It also provides calculated values for calories (energy). These measurements, in conjunction with other clinical assessments, may be used to aid in the nutritional management of newborns, including preterm, and infants.
This device is intended for use in healthcare by trained healthcare personnel at point of care or clinical laboratory settings.
The device is for prescription use only.
Device Description
The Emily's Care Nourish Test System (Model 1) is an in vitro diagnostic device that consists of the following:
- 1. iPhone models 12 mini. 12 pro. 12 pro max. 13. 13 pro max, 14 or 14 pro max running iOS 16 or 17
- 2. Free Emily's Care app to be downloaded on the iPhone app store
- 3. Single-use test strips, in a desiccant-lined vial
- 4. Single-use reference card to place the test strip on to be read
- 5. Pipettes and tubes to collect milk
- 6. Lightbox
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