GEM TECHNOLOGY CO.,LTD · 89-08 · CHINA
For GEM TECHNOLOGY 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 "Drug Abuse Test" IVD kit; product code is 91 L - - AF Gas Chromatography, Methamphetamine; date published is 09/05/2017; address is NO. 20 BOSONG ROAD ZHEN , HENAN, CHINA, verified against its source on 2026-09-16.
- Firm
- GEM TECHNOLOGY 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
- NO. 20 BOSONG ROAD ZHEN , HENAN, CHINA verified
- Date published
- 09/05/2017 verified
- Product code
- 91 L - - AF Gas Chromatography, Methamphetamine verified
- Product
- "Drug Abuse Test" IVD kit verified
- FDA notes
- The product labeling; for the device; "Device Abuse Test;" appears to be lack adequate directions for use. Device Classification is unknown. verified
What the source says
GEM TECHNOLOGY CO.,LTD Date Published : 09/05/2017 NO. 20 BOSONG ROAD ZHEN , HENAN, CHINA 91 L - - AF Gas Chromatography, Methamphetamine Date Published: 09/05/2017 Desc: "Drug Abuse Test" IVD kit Notes: The product labeling; for the device; "Device Abuse Test;" appears to be lack adequate directions for use. Device Classification is unknown.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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