Amoy Diagnostics Co. Ltd. · 89-08 · CHINA
For Amoy Diagnostics 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 Mutation Detection Kit | Mutation Detection Kit; product code is 81 M - - VU Reagents, Specific, Analyte | 88 N - - QF Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor; date published is 05/24/2013; address is 5th Floor, No. 4 Plant, Kechuang Ctr , 289 Wengjiao Rd., Xinyang St., Haicang , Xiamen, Fujian, CHINA, verified against its source on 2026-09-30.
- Firm
- Amoy Diagnostics 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
- 5th Floor, No. 4 Plant, Kechuang Ctr , 289 Wengjiao Rd., Xinyang St., Haicang , Xiamen, Fujian, CHINA verified
- Date published
- 05/24/2013 verified
- Product code
- 81 M - - VU Reagents, Specific, Analyte | 88 N - - QF Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor each item verified
- Product
- Mutation Detection Kit | Mutation Detection Kit each item verified
- FDA notes
- Class III | class III each item verified
What the source says
Amoy Diagnostics Co. Ltd. Date Published : 05/24/2013 5th Floor, No. 4 Plant, Kechuang Ctr , 289 Wengjiao Rd., Xinyang St., Haicang , Xiamen, Fujian, 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
81 M - - VU Reagents, Specific, Analyte Date Published: 05/24/2013 Desc: Mutation Detection Kit Notes: Class III 88 N - - QF Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor Date Published: 05/24/2013 Desc: Mutation Detection Kit Notes: class III
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html