510(k) DEN180007
- Device
- Miris Human Milk Analyzer
- Applicant
- Miris AB
- 510(k) number
- DEN180007
- Product code
- QEI
- Decision
- Unknown (DENG)
- Decision date
- 2018-12-21
- Date received
- 2018-02-12
- Regulation
- 862.1493
- Classification name
- Breast Milk Macronutrients Test System
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Elin Hallen
- Address
- Kungsgatan 115 Uppsala SE 753 18 753 18
FDA Registration Numbers#
- 3013887826
Source Documents#
510(k) summary PDF not indicated by FDA