Medical Device Manufacturer · FR , Marcy-L'?toile

Biom?rieux - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2023
2
Total
2
Cleared
0
Denied

Biom?rieux has 2 FDA 510(k) cleared medical devices. Based in Marcy-L'?toile, FR.

Latest FDA clearance: Jun 2025. Active since 2023. Primary specialty: Microbiology.

Browse the FDA 510(k) cleared devices submitted by Biom?rieux Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Biomérieux as regulatory consultant. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.

FDA 510(k) Regulatory Record - Biom?rieux
2 devices
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