The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for Wondfo One Step Buprenorphine Urine Test, Oxycodone Urine Test, Propoxphene Urine Test, Multiple Drug Of Abuse Urine Tes.
| Device ID | K093175 |
| 510k Number | K093175 |
| Device Name: | WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | Guangzhou Wondfo Biotech Co., Ltd. 1 CONGRESSIONAL DRIVE APT C, Greenville, DE 19807 |
| Contact | Howard Mann |
| Correspondent | Howard Mann Guangzhou Wondfo Biotech Co., Ltd. 1 CONGRESSIONAL DRIVE APT C, Greenville, DE 19807 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-08 |
| Decision Date | 2010-08-25 |
| Summary: | summary |