The following data is part of a premarket notification filed by Healstone Biotech Inc with the FDA for Accurate Multi Panel Drug Urine Test Cup.
| Device ID | K191841 |
| 510k Number | K191841 |
| Device Name: | Accurate Multi Panel Drug Urine Test Cup |
| Classification | Test, Amphetamine, Over The Counter |
| Applicant | Healstone Biotech Inc Unit 650 - 655 West Kent Avenue North Vancouver, CA V6p 6t7 |
| Contact | Bryan Fang |
| Correspondent | Joe Shia LSI International Inc. 504 East Diamond Ave. Suite I Gaithersburg, MD 20877 |
| Product Code | NFT |
| Subsequent Product Code | NFV |
| Subsequent Product Code | NFW |
| Subsequent Product Code | NFY |
| Subsequent Product Code | NGG |
| Subsequent Product Code | NGL |
| Subsequent Product Code | NGM |
| 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 | 2019-07-09 |
| Decision Date | 2019-08-07 |