The following data is part of a premarket notification filed by Assure Tech (hangzhou) Co., Ltd. with the FDA for Assuretech Doa Dipstick Screen Panel Tests, Assuretech Doa Integrated Cup Tests.
| Device ID | K201630 |
| 510k Number | K201630 |
| Device Name: | AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | Assure Tech (Hangzhou) Co., Ltd. 2nd-5th Floor, Building 4, No. 1418-50, Moganshan Road, Gongshu District Hangzhou, CN 310011 |
| Contact | Shisheng Ling |
| Correspondent | Joe Shia LSI International 504 E Diamond Ave., Suite I Gaithersburg, MD 20877 |
| Product Code | DJG |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJR |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | JXM |
| Subsequent Product Code | JXN |
| Subsequent Product Code | LAF |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-16 |
| Decision Date | 2021-08-12 |