The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for Wondfo Multi-drug Urine Test Cup Wondfo Multi-drug Urine Test Panel.
| Device ID | K121166 |
| 510k Number | K121166 |
| Device Name: | WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE SUITE F Gaithersburg, MD 20878 |
| Contact | Joe Shia |
| Correspondent | Joe Shia Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE SUITE F Gaithersburg, MD 20878 |
| Product Code | DIO |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | LAF |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-17 |
| Decision Date | 2012-05-08 |
| Summary: | summary |