YORKTEST LABORATORIES LIMITED · 89-08 · UNITED KINGDOM
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
- 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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