The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for Wondfo T-cup Multi-drug Urine Test Cup.
| Device ID | K182701 |
| 510k Number | K182701 |
| Device Name: | Wondfo T-Cup Multi-Drug Urine Test Cup |
| Classification | Test, Amphetamine, Over The Counter |
| Applicant | Guangzhou Wondfo Biotech Co., Ltd. No.8 Lizhishan Road, Science City Guangzhou, CN 510641 |
| Contact | Bin Chen |
| Correspondent | Joe Shia LSI International 504 E Diamond Ave., Suite I Gaithersburg, MD 20877 |
| Product Code | NFT |
| Subsequent Product Code | LCK |
| 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 | 2018-09-27 |
| Decision Date | 2018-12-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817405021048 | K182701 | 000 |
| 00817405021192 | K182701 | 000 |
| 00817405021185 | K182701 | 000 |
| 00817405021178 | K182701 | 000 |
| 00817405021161 | K182701 | 000 |
| 00817405021154 | K182701 | 000 |
| 00817405021147 | K182701 | 000 |
| 00817405021130 | K182701 | 000 |
| 10193489017519 | K182701 | 000 |
| 10817405021366 | K182701 | 000 |
| 00817405021376 | K182701 | 000 |
| 20193489017547 | K182701 | 000 |
| 00817405021208 | K182701 | 000 |
| 00817405021215 | K182701 | 000 |
| 00817405021031 | K182701 | 000 |
| 00817405021024 | K182701 | 000 |
| 00817405021017 | K182701 | 000 |
| 00817405021000 | K182701 | 000 |
| 00817405021086 | K182701 | 000 |
| 00817405020973 | K182701 | 000 |
| 10817405021298 | K182701 | 000 |
| 00817405021260 | K182701 | 000 |
| 00817405021246 | K182701 | 000 |
| 00817405021239 | K182701 | 000 |
| 00817405021222 | K182701 | 000 |
| 10817405022226 | K182701 | 000 |