Assure Tech (Hangzhou) Co., Ltd · 89-08 · CHINA
For Assure Tech (Hangzhou) Co., Ltd, import alert is 89-08; country is CHINA; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is Rapid Response COVID-19 Antigen Rapid Test Device; product code is 83 Q - - KP Coronavirus antigen detection test system; date published is 06/22/2021; address is Nd-5th Floor, Building 4 1418 , 50 Moganshan Road; Gongshu , Hangzhou, Zhejiang CHINA, verified against its source on 2026-09-30.
- Firm
- Assure Tech (Hangzhou) Co., Ltd verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- CHINA verified
- Address
- Nd-5th Floor, Building 4 1418 , 50 Moganshan Road; Gongshu , Hangzhou, Zhejiang CHINA verified
- Date published
- 06/22/2021 verified
- Product code
- 83 Q - - KP Coronavirus antigen detection test system. verified
- Product
- Rapid Response COVID-19 Antigen Rapid Test Device verified
What the source says
Assure Tech (Hangzhou) Co., Ltd Date Published : 06/22/2021 Nd-5th Floor, Building 4 1418 , 50 Moganshan Road; Gongshu , Hangzhou, Zhejiang CHINA
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/22/2021 Desc: Rapid Response COVID-19 Antigen Rapid Test Device
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html