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

Biom?rieux SA - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2020

Total

Cleared

Denied

Biom?rieux SA has 3 FDA 510(k) cleared medical devices. Based in Marcy-L'?toile, FR.

Latest FDA clearance: Apr 2026. Active since 2020. Primary specialty: Microbiology.

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

Regulatory submissions have been managed by Biomérieux SA and Biomérieux. 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 SA

3 devices

1-3 of 3

Cleared Apr 21, 2026

ETEST Gepotidacin (GEP) (0.016-256 µg/mL)

ETEST Plazomicin (PLZ) (0.016-256 µg/mL)

K200512 · JWY

Microbiology · 66d

Regulatory Intelligence

PCCP authorized FDA software change control pathway

Regulatory consultants 510(k) submission support ecosystem

Biomérieux SA

Biomérieux

Regulatory activity signals

510(k) clearance pathway relevance detected

Medical device regulatory intelligence node

Consulting ecosystem involvement present

Data Source

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

Last updated: May 08, 2026

Biom?rieux SA - FDA 510(k) Cleared Devices

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