PRENETICS LIMITED · 89-08 · HONG KONG SAR
For PRENETICS LIMITED, import alert is 89-08; country is HONG KONG SAR; 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 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 2026-09-30.
- 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
— 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.
Product code and Product
83 Q - - LW COVID-19 test home collection kit devices Date Published: 11/15/2021 Desc: Circle HealthPod Rapid Detention System for Covid 19
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html