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 | K180349 |
| 510k Number | K180349 |
| Device Name: | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests |
| Classification | Test, Amphetamine, Over The Counter |
| Applicant | Assure Tech (Hangzhou) Co., Ltd. No. 10, Xiyuansan Rd., Westlake Economic Zone Hangzhou, CN 310030 |
| 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 | 2018-02-08 |
| Decision Date | 2018-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00722066004562 | K180349 | 000 |
| 00722066004784 | K180349 | 000 |
| 10722066005313 | K180349 | 000 |
| 30681066053998 | K180349 | 000 |
| 30681066053707 | K180349 | 000 |
| 30681066049601 | K180349 | 000 |
| 30021331054501 | K180349 | 000 |
| 00722066007563 | K180349 | 000 |
| 00722066007556 | K180349 | 000 |
| 00722066007549 | K180349 | 000 |
| 00722066007754 | K180349 | 000 |
| 00722066008263 | K180349 | 000 |
| 00722066008256 | K180349 | 000 |
| 00722066008126 | K180349 | 000 |
| 00722066008096 | K180349 | 000 |
| 00722066008058 | K180349 | 000 |
| 00722066007952 | K180349 | 000 |
| 00722066007945 | K180349 | 000 |
| 00722066005309 | K180349 | 000 |
| 00722066004586 | K180349 | 000 |
| 00722066004548 | K180349 | 000 |
| 00722066004524 | K180349 | 000 |
| 00722066004500 | K180349 | 000 |
| 06952804802639 | K180349 | 000 |
| 06952804802622 | K180349 | 000 |
| 06952804802615 | K180349 | 000 |
| 06952804802608 | K180349 | 000 |
| 00722066004814 | K180349 | 000 |
| 00722066004913 | K180349 | 000 |
| 00722066005088 | K180349 | 000 |
| 00722066005095 | K180349 | 000 |
| 00722066004791 | K180349 | 000 |
| 00722066004722 | K180349 | 000 |
| 00722066004678 | K180349 | 000 |
| 00722066004647 | K180349 | 000 |
| 00722066004630 | K180349 | 000 |
| 00722066004593 | K180349 | 000 |
| 00722066007402 | K180349 | 000 |