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 |