The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for Wondfo Amphetamine Urine Test, Wondfo Barbiturates Urine Test, Wondfo Benzodiazepines Urine Test.
| Device ID | K111560 |
| 510k Number | K111560 |
| Device Name: | WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST |
| Classification | Enzyme Immunoassay, Amphetamine |
| 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 | DKZ |
| Subsequent Product Code | DIX |
| Subsequent Product Code | JXM |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-03 |
| Decision Date | 2011-07-15 |
| Summary: | summary |