Meikang Biological Project Co., Ltd., · 89-08 · CHINA
For Meikang Biological Project Co., Ltd.,, import alert is 89-08; country is CHINA; 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 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 4633 Pusan Road , Shanghai, CHINA, verified against its source on 2026-09-30.
- Firm
- Meikang Biological Project Co., 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
- CHINA verified
- Address
- 4633 Pusan Road , Shanghai, 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
- 11/14/2008;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
Meikang Biological Project Co., Ltd., Date Published : 01/07/2011 4633 Pusan Road , Shanghai, CHINA
— 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 J - - HI Radioimmunoassay, Human Chorionic Gonadotropin Date Published: 01/07/2011 Desc: All IVD Tests Notes: 11/14/2008;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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html