Assure Tech (Hangzhou) Co., Ltd · 89-08 · CHINA
For Assure Tech (Hangzhou) Co., Ltd · 89-08 · CHINA, import alert is 89-08; 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)"; country is CHINA; 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 2026-09-16.
- 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 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/22/2021 Desc: Rapid Response COVID-19 Antigen Rapid Test Device
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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