The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for Wondfo T-dip Multi-drug Urine Test Panel, Wondfo T-dip Multi-drug Urine Test Panel Rx.
| Device ID | K202567 |
| 510k Number | K202567 |
| Device Name: | Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx |
| Classification | Test, Amphetamine, Over The Counter |
| Applicant | Guangzhou Wondfo Biotech Co., Ltd. No. 8 Lizhishan Road, Science City Guangzhou, CN 510641 |
| Contact | Yi Mei |
| Correspondent | Joe Shia LSI International 504 E Diamond Ave., Suite I Gaithersburg, MD 20877 |
| Product Code | NFT |
| Subsequent Product Code | LCM |
| Subsequent Product Code | NFV |
| Subsequent Product Code | NFW |
| Subsequent Product Code | NFY |
| Subsequent Product Code | NGG |
| Subsequent Product Code | NGL |
| Subsequent Product Code | PTG |
| Subsequent Product Code | PTH |
| Subsequent Product Code | QAW |
| Subsequent Product Code | QBF |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-04 |
| Decision Date | 2020-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816862023678 | K202567 | 000 |
| 10816862023982 | K202567 | 000 |
| 10816862024002 | K202567 | 000 |
| 10816862024026 | K202567 | 000 |
| 30817405023456 | K202567 | 000 |
| 30817405023463 | K202567 | 000 |
| 30817405023586 | K202567 | 000 |
| 30817405023593 | K202567 | 000 |
| 30817405023784 | K202567 | 000 |
| 30817405024002 | K202567 | 000 |
| 30817405024019 | K202567 | 000 |
| 00810038633367 | K202567 | 000 |
| 10810038630622 | K202567 | 000 |
| 10816862023654 | K202567 | 000 |
| 10816862023036 | K202567 | 000 |