The following data is part of a premarket notification filed by Vivachek Biotech (hangzhou) Co., Ltd with the FDA for Wisdiag Multi-drug Urine Test Cup, Wisdiag Multi-drug Urine Test Cup Rx.
| Device ID | K222667 |
| 510k Number | K222667 |
| Device Name: | Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx |
| Classification | Test, Amphetamine, Over The Counter |
| Applicant | Vivachek Biotech (Hangzhou) Co., Ltd Level 2, Block 2, 146 East Chaofeng Road Yuhang Economy Development Zone Hangzhou, CN 311100 |
| Contact | Jessica Chen |
| Correspondent | Joe Shia LSI International 540 E Diamond Avenue, 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 | 2022-09-06 |
| Decision Date | 2022-11-10 |