Medical Device Manufacturer · SE , Uppsala

Miris AB - FDA 510(k) Cleared Devices

2 submissions · 1 cleared · Since 2018

2

Total

1

Cleared

1

Denied

FDA 510(k) Regulatory Record - Miris AB Chemistry ✕

2 devices

1-2 of 2

Cleared Sep 29, 2023

Miris Human Milk Analyzer (HMA)

Chemistry · 364d

Not Cleared Dec 21, 2018

Miris Human Milk Analyzer

DEN180007 · QEI

Chemistry · 312d

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 16, 2026