Data / Medical devices / Canada / Spectral Medical Inc.
Spectral Medical Inc.: FDA-registered device maker in TORONTO Ontario, Canada, 1 510(k) clearance
Spectral Medical Inc. is registered with the FDA (registration 9617857) in TORONTO Ontario, Canada. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 12, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9617857
- FEI number
- 3000058367
- Address
- 135 The West Mall, Unit 2, TORONTO Ontario, Canada, M9C 1C2
- Owner or operator
- Spectral Medical Inc. (9034643)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- May 30, 2018
- Registered through
- 2026
- Brand names listed
- EAA, Sirius 2 Tube Luminometer, Smart Line TL Luminometer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Assay, Endotoxin Activity, Chemiluminescent | NGS | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| March 12, 2019 | K183176 | Endotoxin Activity Assay (EAA) | NGS | Substantially Equivalent | Spectral Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Updated March 12, 2019. 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.