510(k) K234088
- Device
- Emily's Care Nourish Test System (Model 1)
- Applicant
- Lactation Lab, Inc.
- 510(k) number
- K234088
- Product code
- QEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-05-03
- Date received
- 2023-12-22
- Regulation
- 862.1493
- Classification name
- Breast Milk Macronutrients Test System
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Stephanie Canale
- Address
- 2611 Palm Ave. Manhattan Beach CA US 90266 90266
FDA Registration Numbers#
- 3013887826