FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD · 89-08 · CHINA

For FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)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 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 2026-09-30.

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

— 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.

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.