K223085
- 510(k) number
- K223085
- Device name
- Miris Human Milk Analyzer (HMA)
- Applicant
- Miris AB SE
- Product code
- QEI — Breast Milk Macronutrients Test System
- Decision date
- 2023-09-29
- Date received
- 2022-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K223085.pdf
Official FDA record: K223085
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.