The following data is part of a premarket notification filed by Qingdao Hightop Biotech Co., Ltd. with the FDA for Hightop Multi-drug Urine Test Cup, Hightop Multi-drug Urine Test Cup Rx.
| Device ID | K220685 |
| 510k Number | K220685 |
| Device Name: | HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx |
| Classification | Test, Amphetamine, Over The Counter |
| Applicant | Qingdao HIGHTOP Biotech Co., Ltd. No.369 Hedong Road, Hi-tech Industrial Development Zone Qingdao, CN 266112 |
| Contact | Ray Li |
| 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 | 2022-03-08 |
| Decision Date | 2022-05-05 |