Data / Medical devices / Canada / Dormer Laboratories, Inc.
Dormer Laboratories, Inc.: FDA-registered device maker in Toronto Ontario, Canada, 1 510(k) clearance
Dormer Laboratories, Inc. is registered with the FDA (registration 9616619) in Toronto Ontario, Canada. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 12, 2000. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9616619
- FEI number
- 3001344828
- Address
- 91 Kelfield ST., Unit 5, Toronto Ontario, Canada, M9W 5A3
- Owner or operator
- DORMER LABORATORIES (9041255)
- Roles
- Repackager or relabeler
- First device listed
- December 4, 2007
- Registered through
- 2027
- Brand names listed
- KXF / SYSTEM, DELIVERY, ALLERGEN AND VACCINE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| April 12, 2000 | K992553 | IQ CHAMBERS | KXF | Substantially Equivalent | Dormer Laboratories, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 12, 2000. 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.