FDA Device Establishments · JSON-LD · Markdown
FEI 3000058367 · Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device · Status: Active
| FEI Number | 3000058367 |
|---|---|
| Owner / Operator | Spectral Medical Inc. (#9034643) |
| Address | 135 The West Mall, Unit 2, TORONTO Ontario, M9C 1C2, CA |
| Mandatory US Agent | Beaufort |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | LXG |
| Regulation § (21 CFR) | 862.2050 |
| Proprietary names | Smart Line TL Luminometer; Sirius 2 Tube Luminometer |
Source: openFDA. Public-domain (CC0).