Shanghai Meikang Biological Project Co. · 89-08 · CHINA
For Shanghai Meikang Biological Project Co. · 89-08 · CHINA, 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 CHINA; product is All IVD Tests | All IVD Tests | All IVD Tests; product code is 75 J - - HI Radioimmunoassay, Human Chorionic Gonadotropin | 75 L - - CX Kit, Test, Pregnancy, HCG, Over the Counter | 83 G - - TY Antigens, All Groups, Streptococcus Spp; date published is 01/07/2011; address is No 25 1150 Shenkanglu , Kangqiao Town, Pudong , Shanghaishi, Shanghaishi CHINA, verified against its source on 2026-09-16.
- Firm
- Shanghai Meikang Biological Project Co. 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
- CHINA verified
- Address
- No 25 1150 Shenkanglu , Kangqiao Town, Pudong , Shanghaishi, Shanghaishi CHINA verified
- Date published
- 01/07/2011 verified
- Product code
- 75 J - - HI Radioimmunoassay, Human Chorionic Gonadotropin | 75 L - - CX Kit, Test, Pregnancy, HCG, Over the Counter | 83 G - - TY Antigens, All Groups, Streptococcus Spp. each item verified
- Product
- All IVD Tests | All IVD Tests | All IVD Tests each item verified
- FDA notes
- 11/14/08;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits are not subject to DWPE | 11/14/08;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits are not subject to DWPE | 11/14/08;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits are not subject to DWPE each item verified
What the source says
Shanghai Meikang Biological Project Co. Date Published : 01/07/2011 No 25 1150 Shenkanglu , Kangqiao Town, Pudong , Shanghaishi, Shanghaishi CHINA 75 J - - HI Radioimmunoassay, Human Chorionic Gonadotropin Date Published: 01/07/2011 Desc: All IVD Tests Notes: 11/14/08;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits are not subject to DWPE 75 L - - CX Kit, Test, Pregnancy, HCG, Over the Counter Date Published: 01/07/2011 Desc: All IVD Tests Notes: 11/14/08;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits are not subject to DWPE 83 G - - TY Antigens, All Groups, Streptococcus Spp. Date Published: 01/07/2011 Desc: All IVD Tests Notes: 11/14/08;Note: CDRH indicates that Mainline Maxie HCG Urine Pregnancy Test Kits are not subject to DWPE
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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