PRENETICS LIMITED · 89-08 · HONG KONG SAR
For PRENETICS LIMITED · 89-08 · HONG KONG SAR, 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 HONG KONG SAR; product is Circle HealthPod Rapid Detention System for Covid 19; product code is 83 Q - - LW COVID-19 test home collection kit devices; date published is 11/15/2021; address is 701-706,K11 Atelier King's Road , 728 King's Road , Quarry Bay, HONG KONG SAR, verified against its source on 2026-09-16.
- Firm
- PRENETICS LIMITED 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
- HONG KONG SAR verified
- Address
- 701-706,K11 Atelier King's Road , 728 King's Road , Quarry Bay, HONG KONG SAR verified
- Date published
- 11/15/2021 verified
- Product code
- 83 Q - - LW COVID-19 test home collection kit devices verified
- Product
- Circle HealthPod Rapid Detention System for Covid 19 verified
What the source says
PRENETICS LIMITED Date Published : 11/15/2021 701-706,K11 Atelier King's Road , 728 King's Road , Quarry Bay, HONG KONG SAR 83 Q - - LW COVID-19 test home collection kit devices Date Published: 11/15/2021 Desc: Circle HealthPod Rapid Detention System for Covid 19
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.