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 300), Wondfo Methamphetamine Urine Test (met 500).
| Device ID | K122961 |
| 510k Number | K122961 |
| Device Name: | WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500) |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE. Suite F Gaithersburg, MD 20877 |
| Contact | Joe Shia |
| Correspondent | Joe Shia Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE. Suite F Gaithersburg, MD 20877 |
| Product Code | DKZ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-25 |
| Decision Date | 2012-12-21 |
| Summary: | summary |