# YORKTEST LABORATORIES LIMITED · 89-08 · UNITED KINGDOM — FDA import alert red lists: firms subject to detention without physical examination

For YORKTEST LABORATORIES LIMITED · 89-08 · UNITED KINGDOM, 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 UNITED KINGDOM; 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 2026-09-16.

- **Firm:** YORKTEST LABORATORIES LIMITED _(verified: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Triune Court , Monks Cross Drive , York, YOR UNITED KINGDOM _(verified: appears in the quote below)_
- **Date published:** 04/08/2019 _(verified: appears in the quote below)_
- **Product code:** 75 J - - KA Tubes, Vials, Systems, Serum Separators, Blood Collection _(verified: appears in the quote below)_
- **Product:** Food Intolerance Testing Kits _(verified: appears in the quote below)_
- **FDA notes:** Class II device without a valid 501K _(verified: appears in the quote below)_

## What the source says

> YORKTEST LABORATORIES LIMITED Date Published : 04/08/2019 Triune Court , Monks Cross Drive , York, YOR UNITED KINGDOM 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).