Amoy Diagnostics Co. Ltd. · 89-08 · CHINA
For Amoy Diagnostics Co. Ltd. · 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 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 2026-09-16.
- 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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