The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for Wondfo Propoxyphene Urine Test.
| Device ID | K152495 |
| 510k Number | K152495 |
| Device Name: | Wondfo Propoxyphene Urine Test |
| Classification | Enzyme Immunoassay, Propoxyphene |
| Applicant | Guangzhou Wondfo Biotech Co., Ltd. Wondfo Scientech Park, South China Univ. Of Technology Guangzhou, CN 510641 |
| Contact | Ben Chen |
| Correspondent | Joe Shia LSI International Inc. 504 East Diamond Ave. Suite I Gaithersburg, MD 20877 |
| Product Code | JXN |
| CFR Regulation Number | 862.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-01 |
| Decision Date | 2015-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816036025623 | K152495 | 000 |