Ark Bio Medical Canada Corp · 89-08 · CANADA
For Ark Bio Medical Canada Corp, import alert is 89-08; country is CANADA; 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 Ark Bio Microwave Plasma Defroster; product code is 81 K - - ZL Device, Warming, Blood and Plasma; date published is 10/07/2016; address is 671 Rustico Rd - Rte 7 , North Milton, Prince Edward Island CANADA, verified against its source on 2026-09-30.
- Firm
- Ark Bio Medical Canada Corp 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
- CANADA verified
- Address
- 671 Rustico Rd - Rte 7 , North Milton, Prince Edward Island CANADA verified
- Date published
- 10/07/2016 verified
- Product code
- 81 K - - ZL Device, Warming, Blood and Plasma verified
- Product
- Ark Bio Microwave Plasma Defroster verified
What the source says
Ark Bio Medical Canada Corp Date Published : 10/07/2016 671 Rustico Rd - Rte 7 , North Milton, Prince Edward Island CANADA
— 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
81 K - - ZL Device, Warming, Blood and Plasma Date Published: 10/07/2016 Desc: Ark Bio Microwave Plasma Defroster
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html