# Casebioscience, Inc.

- Location (FDA's records): Guelph, CA
- FDA decisions: 2 (2025–2026): 2 510(k) clearances
- Product codes: MQL (2)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Gimbo Medical Technology Shenzhen Co., Ltd.: 1 (https://510kreport.com/company/gimbo-medical-technology-shenzhen)

## Its most-cited devices
- K242107: CaseMONO™ Culture  (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) (2025), cited by 1

## Recent decisions
- K252672: CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5) (Feb 20, 2026)
- K242107: CaseMONO™ Culture  (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) (Mar 21, 2025)

Source page: https://510kreport.com/company/casebioscience