FDA Device Establishments · JSON-LD · Markdown
FEI 1000431353 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 1000431353 |
|---|---|
| Owner / Operator | The Hilsinger Company Parent, LLC (#1218954) |
| Address | 5715 W HOWARD ST, NILES, IL, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 1 |
| Product codes (top 20) | QTO |
| Regulation § (21 CFR) | 886.1150 |
| Proprietary names | ColorCheck Color Screening; Smart System PC-Plus; VisiChart; CustomLink; Clinical Trial Suite; Sports Vision Performance; Smart System; Smart System Standard; Protocol One; Smart System 20/20 |
Source: openFDA. Public-domain (CC0).