The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for Wondfo Cocaine Urine Test Model W10-cu, W10-p, Wondfo Methamphetamine Urine Test Model W11-cu, W11-p.
| Device ID | K112071 |
| 510k Number | K112071 |
| Device Name: | WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE. SUITE F Gaithersbrug, MD 20878 |
| Contact | Joe Shia |
| Correspondent | Joe Shia Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE. SUITE F Gaithersbrug, MD 20878 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-20 |
| Decision Date | 2011-09-23 |
| Summary: | summary |