Data / Medical devices / Canada / I-Dialco Inc.
I-Dialco Inc.: FDA-registered device maker in Mississauga Ontario, Canada, 2 510(k) clearances
I-Dialco Inc. is registered with the FDA (registration 3015472042) in Mississauga Ontario, Canada. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated August 28, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015472042
- Address
- 2455 Cawthra Road, Unit 23, Mississauga Ontario, Canada, L5A 3P1
- Owner or operator
- i-Dialco Inc (10060385)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- May 6, 2019
- Registered through
- 2026
- Brand names listed
- MILINE 400, SAMI
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| August 28, 2020 | K193005 | DIMI RRT System | KDI | Substantially Equivalent | Dialco Medical, Inc. | accessdata.fda.gov |
| December 13, 2017 | K170790 | SAM CRRT Unit, SAM Cassette CRRT | KDI | Substantially Equivalent | Spectral Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 28, 2020. 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.