INZEK INTERNATIONAL TRADING · 89-08 · NETHERLANDS
For INZEK INTERNATIONAL TRADING · 89-08 · NETHERLANDS, 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 NETHERLANDS; product is BIOZEK COVID-19 Antigen Rapid Test Cassette (PC; BCOV-502) | Biozek COVID-19 Antigen Rapid Test Cassette | Biozek Antigen Rapid Test; product code is 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system; date published is 05/04/2021; address is Vissenstraat 32 , Apeldoorn, Gelderland NETHERLANDS, verified against its source on 2026-09-16.
- Firm
- INZEK INTERNATIONAL TRADING 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
- NETHERLANDS verified
- Address
- Vissenstraat 32 , Apeldoorn, Gelderland NETHERLANDS verified
- Date published
- 05/04/2021 verified
- Product code
- 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. each item verified
- Product
- BIOZEK COVID-19 Antigen Rapid Test Cassette (PC; BCOV-502) | Biozek COVID-19 Antigen Rapid Test Cassette | Biozek Antigen Rapid Test each item verified
What the source says
INZEK INTERNATIONAL TRADING Date Published : 05/04/2021 Vissenstraat 32 , Apeldoorn, Gelderland NETHERLANDS 83 Q - - KP Coronavirus antigen detection test system. Date Published: 04/04/2022 Desc: BIOZEK COVID-19 Antigen Rapid Test Cassette (PC; BCOV-502) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 05/04/2021 Desc: Biozek COVID-19 Antigen Rapid Test Cassette 83 Q - - KP Coronavirus antigen detection test system. Date Published: 05/04/2021 Desc: Biozek Antigen Rapid Test
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html