The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for Wondfo Cannabinoids Urine Test Wondfo Propoxyphene Urine Test.
| Device ID | K121557 |
| 510k Number | K121557 |
| Device Name: | WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST |
| Classification | Enzyme Immunoassay, Cannabinoids |
| 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 | LDJ |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-25 |
| Decision Date | 2012-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855944007642 | K121557 | 000 |
| 10810038632015 | K121557 | 000 |
| 30810038630152 | K121557 | 000 |
| 00850253007246 | K121557 | 000 |
| 00850253007253 | K121557 | 000 |
| 10850253007298 | K121557 | 000 |
| 10850253007915 | K121557 | 000 |
| 10855944007465 | K121557 | 000 |
| 00855944007475 | K121557 | 000 |
| 00855944007482 | K121557 | 000 |
| 10810038631636 | K121557 | 000 |