The following data is part of a premarket notification filed by Assure Tech (hangzhou) Co., Ltd. with the FDA for Assuretech Panel Dip Test, Assuretech Quick Cup Test.
| Device ID | K170049 |
| 510k Number | K170049 |
| Device Name: | AssureTech Panel Dip Test, AssureTech Quick Cup Test |
| 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 |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-05 |
| Decision Date | 2017-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06952804802653 | K170049 | 000 |
| 06952804801656 | K170049 | 000 |
| 06952804801809 | K170049 | 000 |
| 06952804801816 | K170049 | 000 |
| 06952804801823 | K170049 | 000 |
| 06952804801885 | K170049 | 000 |
| 06952804801892 | K170049 | 000 |
| 06952804801946 | K170049 | 000 |
| 06952804802646 | K170049 | 000 |
| 06952804801649 | K170049 | 000 |