VIVOSENS BIYOTEKNOLOJI AR-GE, SAN. & TIC. LTD. STI · 89-08 · TURKEY
For VIVOSENS BIYOTEKNOLOJI AR-GE, SAN. & TIC. LTD. STI, import alert is 89-08; country is TURKEY; 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 Vivoo Test Strips; product code is 75 L - - XG Equipment, Laboratory, General Purpose, Labeled or Promoted for a Specific Medical Use; date published is 09/30/2019; address is Teknokent Ari 1 Sit. No: 2 5 15 , Sariyer, Sariyer Istanbul TURKEY, verified against its source on 2026-09-30.
- Firm
- VIVOSENS BIYOTEKNOLOJI AR-GE, SAN. & TIC. LTD. STI 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
- TURKEY verified
- Address
- Teknokent Ari 1 Sit. No: 2 5 15 , Sariyer, Sariyer Istanbul TURKEY verified
- Date published
- 09/30/2019 verified
- Product code
- 75 L - - XG Equipment, Laboratory, General Purpose, Labeled or Promoted for a Specific Medical Use verified
- Product
- Vivoo Test Strips verified
- FDA notes
- Class II device that requires 510(k) clearance verified
What the source says
VIVOSENS BIYOTEKNOLOJI AR-GE, SAN. & TIC. LTD. STI Date Published : 09/30/2019 Teknokent Ari 1 Sit. No: 2 5 15 , Sariyer, Sariyer Istanbul TURKEY
— 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 L - - XG Equipment, Laboratory, General Purpose, Labeled or Promoted for a Specific Medical Use Date Published: 09/30/2019 Desc: Vivoo Test Strips Notes: Class II device that requires 510(k) clearance
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html