WALLAC OY · 89-08 · FINLAND
For WALLAC OY, import alert is 89-08; country is FINLAND; 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 GSP/DELFIA Anti-SARS-CoV-2 IgG Kit; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 03/11/2021; address is Mustionkatu 6 , Turku Varsinais-Suomi, Southwest Finland FINLAND, verified against its source on 2026-09-30.
- Firm
- WALLAC OY 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
- FINLAND verified
- Address
- Mustionkatu 6 , Turku Varsinais-Suomi, Southwest Finland FINLAND verified
- Date published
- 03/11/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- GSP/DELFIA Anti-SARS-CoV-2 IgG Kit verified
What the source says
WALLAC OY Date Published : 03/11/2021 Mustionkatu 6 , Turku Varsinais-Suomi, Southwest Finland FINLAND
— 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 - - KO Reagent, coronavirus serological Date Published: 03/11/2021 Desc: GSP/DELFIA Anti-SARS-CoV-2 IgG Kit
— all from 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.