Medical Device Manufacturer · CA , Guelph

Casebioscience, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2025

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Casebioscience, Inc. Obstetrics & Gynecology ✕

2 devices

1-2 of 2

Cleared Feb 20, 2026

CaseBio™ Culture w/HSA (CMH5)

Obstetrics & Gynecology · 179d

Cleared Mar 21, 2025

CaseMONO™ Culture (CMON)

Obstetrics & Gynecology · 246d