Shenzhen Superbio Technology Co., Ltd.
Brand owner, China. 4 products catalogued, 1 clearance.
Shenzhen Superbio Technology Co., Ltd. holds an FDA establishment registration in China. Its registration names no device type; it is in this index because it catalogues devices under its own name. 4 of its products are catalogued under its own name.
4products catalogued under its own name
1510(k) clearance
Registration
| Status | Not current |
|---|---|
| DUNS | 724542368 |
Location
| Country | China |
|---|
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| S-Trust Fentanyl Urine Detection Kit (Fluorescence Immunochromatographic Assay) | DJG | 1 |
| U-Catch Fentanyl Urine Detection Kit (Fluorescence Immunochromatographic Assay) | DJG | 1 |
| Bioeasy Immunofluorescence Analyzer | KHO | 1 |
| Superbio Immunofluorescence Analyzer | KHO | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K220046 | 2022-12-13 | DJG | Traditional | This company |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.