FDA Device Establishments · JSON-LD · Markdown
FEI 3006755541 · Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3006755541 |
|---|---|
| Owner / Operator | BIONIME USA CORPORATION (#10024947) |
| Address | 1450 E. Spruce Street, Bldg. #B, Ontario, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 2 |
| Product codes (top 20) | NBW, LFR |
| Regulation § (21 CFR) | 862.1345 |
| Proprietary names | GE200 Blood Glucose Monitoring System; GE300 Talking Blood Glucose Monitoring System; Rightest Blood Glucose Monitoring System GM700; Rightest Blood Glucose Monitoring System GM650 |
Source: openFDA. Public-domain (CC0).