# FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)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 SARS-CoV-2 Antigen Test Kit | Covid 19 Antigen Self Test Kit | SARS-CoV-2 Antigen Test Kit | Covid 19 Antigen Self Test Kit | SARS-CoV-2 Antigen Test Kit | Covid 19 Antigen Self Test Kit; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - LW COVID-19 test home collection kit devices | 83 Q - - MN COVID-19 Multi-Analyte Antigen Device; date published is 04/12/2022; address is No. 1304 Science And Technology Innovation Park, Shajing Dahong , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-16.

- **Firm:** FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD _(verified: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** No. 1304 Science And Technology Innovation Park, Shajing Dahong , Shenzhen, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 04/12/2022 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - LW COVID-19 test home collection kit devices | 83 Q - - MN COVID-19 Multi-Analyte Antigen Device _(verified: each item appears in the quote below)_
- **Product:** SARS-CoV-2 Antigen Test Kit | Covid 19 Antigen Self Test Kit | SARS-CoV-2 Antigen Test Kit | Covid 19 Antigen Self Test Kit | SARS-CoV-2 Antigen Test Kit | Covid 19 Antigen Self Test Kit _(verified: each item appears in the quote below)_

## What the source says

> FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD Date Published : 04/12/2022 No. 1304 Science And Technology Innovation Park, Shajing Dahong , Shenzhen, Guangdong CHINA 83 Q - - KO Reagent, coronavirus serological Date Published: 04/12/2022 Desc: SARS-CoV-2 Antigen Test Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 04/12/2022 Desc: Covid 19 Antigen Self Test Kit 83 Q - - KP Coronavirus antigen detection test system. Date Published: 04/12/2022 Desc: SARS-CoV-2 Antigen Test Kit 83 Q - - KP Coronavirus antigen detection test system. Date Published: 04/12/2022 Desc: Covid 19 Antigen Self Test Kit 83 Q - - LW COVID-19 test home collection kit devices Date Published: 04/12/2022 Desc: SARS-CoV-2 Antigen Test Kit 83 Q - - MN COVID-19 Multi-Analyte Antigen Device Date Published: 04/12/2022 Desc: Covid 19 Antigen Self Test Kit

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).