FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD · 89-08 · CHINA
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
- 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
- No. 1304 Science And Technology Innovation Park, Shajing Dahong , Shenzhen, Guangdong CHINA verified
- Date published
- 04/12/2022 verified
- 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 each item verified
- 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 each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html