The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for Wondfo Amphetamine Urine Test Amp 500 (cup, Dipcard), Wondfo Cocaine Urine Test Coc 150(cup, Dipcard), Wondfo Methamphetamine Urine Test Met 500 (cup, Dipcard).
| Device ID | K161214 |
| 510k Number | K161214 |
| Device Name: | Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard) |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | GUANGZHOU WONDFO BIOTECH CO., LTD. WONDFO SCIENTECH PARK, SOUTH CHINA UNIV. OF TECHNOLOGY Guangzhou, CN 510641 |
| Contact | Bin Chen |
| Correspondent | Joe Shia LSI INTERNATIONAL 504 E DIAMOND AVE., SUITE I Gaithersburg, MD 20877 |
| Product Code | DIO |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DKZ |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-29 |
| Decision Date | 2016-06-27 |
| Summary: | summary |