Data / Medical devices / Canada / Casebioscience, Inc.
Casebioscience, Inc.: FDA-registered device maker in Guelph Ontario, Canada, 2 510(k) clearances
Casebioscience, Inc. is registered with the FDA (registration 3025773437) in Guelph Ontario, Canada. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 20, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025773437
- Address
- 24 Norwich Street East, Guelph Ontario, Canada, N1H 2G6
- Owner or operator
- CaseBioscience, Inc. (10088718)
- Roles
- Foreign private label distributor, Manufacturer
- First device listed
- October 11, 2023
- Registered through
- 2026
- Brand names listed
- CaseBioscience® PBS1X-Dulbecco's Phosphate Buffered Saline Solution, CaseBio® Culture, CaseBio® Culture w/HSA, CaseBio® HTF, CaseBio® HTF w/HEPES, CaseBio® Handling, CaseBio® Handling w/HSA, CaseBio® Mineral Oil and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Media, Reproductive | MQL | 2 | Manufacturer | accessdata.fda.gov |
| Media, Reproductive, Exempt | QKI | 2 | Foreign private label distributor, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 20, 2026 | K252672 | CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5) | MQL | Substantially Equivalent | Casebioscience, Inc. | accessdata.fda.gov |
| March 21, 2025 | K242107 | CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) | MQL | Substantially Equivalent | Casebioscience, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.