Medical Device Manufacturer · SE , Uppsala

Miris AB - FDA 510(k) Cleared Devices

2 submissions · 1 cleared · Since 2018
2
Total
1
Cleared
1
Denied

Miris AB has 1 FDA 510(k) cleared medical devices. Based in Uppsala, SE.

Last cleared in 2023. Active since 2018. Primary specialty: Chemistry.

Browse the FDA 510(k) cleared devices submitted by Miris AB Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Hogan Lovell US LLP as regulatory consultant.

FDA 510(k) Regulatory Record - Miris AB
2 devices
1-2 of 2
Cleared Sep 29, 2023
Miris Human Milk Analyzer (HMA)
K223085 · QEI
Chemistry · 364d
Not Cleared Dec 21, 2018
Miris Human Milk Analyzer
DEN180007 · QEI
Chemistry · 312d
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