The following data is part of a premarket notification filed by Assure Tech (hangzhou) Co., Ltd. with the FDA for Assuretech Panel Dip Tests, Assuretech Quick Cup Tests.
| Device ID | K181768 |
| 510k Number | K181768 |
| Device Name: | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests |
| Classification | Test, Amphetamine, Over The Counter |
| 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 | 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 | 2018-07-03 |
| Decision Date | 2018-08-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06952804830229 | K181768 | 000 |
| 06952804830212 | K181768 | 000 |
| 00722066004890 | K181768 | 000 |
| 00722066004876 | K181768 | 000 |
| 00722066004906 | K181768 | 000 |
| 00722066005361 | K181768 | 000 |
| 00722066009017 | K181768 | 000 |