Sallamander Concepts (Pty) Ltd · 89-08 · SOUTH AFRICA
For Sallamander Concepts (Pty) Ltd · 89-08 · SOUTH AFRICA, 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 SOUTH AFRICA; product is Sanitoets Urine Test Strips | Sanitoets Prostate home test | Sanitoets Malaria Home test; product code is 75 - - - -- Chemistry | 82 M - - TG Test, Prostate Specific Antigen, Free (Noncomplexed) to Distinguish Prostate Cancer from Benign Cond | 83 O - - AX Plasmodium spp. Detection reagents; date published is 09/07/2010; address is 359 Church Street , Pretoria, Gauteng SOUTH AFRICA, verified against its source on 2026-09-16.
- Firm
- Sallamander Concepts (Pty) Ltd 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
- SOUTH AFRICA verified
- Address
- 359 Church Street , Pretoria, Gauteng SOUTH AFRICA verified
- Date published
- 09/07/2010 verified
- Product code
- 75 - - - -- Chemistry | 82 M - - TG Test, Prostate Specific Antigen, Free (Noncomplexed) to Distinguish Prostate Cancer from Benign Cond | 83 O - - AX Plasmodium spp. Detection reagents each item verified
- Product
- Sanitoets Urine Test Strips | Sanitoets Prostate home test | Sanitoets Malaria Home test each item verified
- FDA notes
- Class II | Class III | Class II each item verified
What the source says
Sallamander Concepts (Pty) Ltd Date Published : 09/07/2010 359 Church Street , Pretoria, Gauteng SOUTH AFRICA 75 - - - -- Chemistry Date Published: 09/07/2010 Desc: Sanitoets Urine Test Strips Notes: Class II 82 M - - TG Test, Prostate Specific Antigen, Free (Noncomplexed) to Distinguish Prostate Cancer from Benign Cond Date Published: 09/07/2010 Desc: Sanitoets Prostate home test Notes: Class III 83 O - - AX Plasmodium spp. Detection reagents Date Published: 09/07/2010 Desc: Sanitoets Malaria Home test Notes: Class II
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html