YORKTEST LABORATORIES LIMITED · 89-08 · UNITED KINGDOM
For YORKTEST LABORATORIES LIMITED, import alert is 89-08; country is UNITED KINGDOM; 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 Food Intolerance Testing Kits; product code is 75 J - - KA Tubes, Vials, Systems, Serum Separators, Blood Collection; date published is 04/08/2019; address is Triune Court , Monks Cross Drive , York, YOR UNITED KINGDOM, verified against its source on 2026-09-30.
- Firm
- YORKTEST LABORATORIES 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
- UNITED KINGDOM verified
- Address
- Triune Court , Monks Cross Drive , York, YOR UNITED KINGDOM verified
- Date published
- 04/08/2019 verified
- Product code
- 75 J - - KA Tubes, Vials, Systems, Serum Separators, Blood Collection verified
- Product
- Food Intolerance Testing Kits verified
- FDA notes
- Class II device without a valid 501K verified
What the source says
YORKTEST LABORATORIES LIMITED Date Published : 04/08/2019 Triune Court , Monks Cross Drive , York, YOR UNITED KINGDOM
— 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, Product and FDA notes
75 J - - KA Tubes, Vials, Systems, Serum Separators, Blood Collection Date Published: 04/08/2019 Desc: Food Intolerance Testing Kits Notes: Class II device without a valid 501K
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html