The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for Wondfo Methadone Urine Test (mtd 200), Wondofo Morphine Urine Test (mop 100).
| Device ID | K131232 |
| 510k Number | K131232 |
| Device Name: | WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) |
| Classification | Enzyme Immunoassay, Methadone |
| 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 | DJR |
| CFR Regulation Number | 862.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-01 |
| Decision Date | 2013-05-31 |
| Summary: | summary |