DFI CO., LTD. · 89-08 · KOREA (THE REPUBLIC OF)
For DFI CO., LTD. · 89-08 · KOREA (THE REPUBLIC OF), 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 KOREA (THE REPUBLIC OF); product is OPTIMAL HEALTH SYSTEMS NITRIC OXIDE TEST STRIPS | OPTIMAL HEALTH SYSTEMS NITRIC OXIDE TEST STRIPS; product code is 75 M - - XA System, Test, Breath Nitric Oxide | 91 M - - IG Strip, Test Isoniazid; date published is 01/04/2016; address is 388-25 Gomo-Ro , Jinrye-Myeon , Gimhae, Gyeongsangnam KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- DFI 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
- KOREA (THE REPUBLIC OF) verified
- Address
- 388-25 Gomo-Ro , Jinrye-Myeon , Gimhae, Gyeongsangnam KOREA (THE REPUBLIC OF) verified
- Date published
- 01/04/2016 verified
- Product code
- 75 M - - XA System, Test, Breath Nitric Oxide | 91 M - - IG Strip, Test Isoniazid each item verified
- Product
- OPTIMAL HEALTH SYSTEMS NITRIC OXIDE TEST STRIPS | OPTIMAL HEALTH SYSTEMS NITRIC OXIDE TEST STRIPS each item verified
What the source says
DFI CO., LTD. Date Published : 01/04/2016 388-25 Gomo-Ro , Jinrye-Myeon , Gimhae, Gyeongsangnam KOREA (THE REPUBLIC OF) 75 M - - XA System, Test, Breath Nitric Oxide Date Published: 01/04/2016 Desc: OPTIMAL HEALTH SYSTEMS NITRIC OXIDE TEST STRIPS 91 M - - IG Strip, Test Isoniazid Date Published: 01/04/2016 Desc: OPTIMAL HEALTH SYSTEMS NITRIC OXIDE TEST STRIPS
— accessdata.fda.gov, retrieved 2026-09-15
The same source also states
DFI Co., Ltd. Date Published : 01/04/2016 388-25 Gomo-Ro , Jillye-Myeon , Gimhae, Gyeongsangnam KOREA (THE REPUBLIC OF) 75 M - - XA System, Test, Breath Nitric Oxide Date Published: 01/04/2016 Desc: OPTIMAL HEALTH SYSTEMS NITRIC OXIDE TEST STRIPS 91 M - - IG Strip, Test Isoniazid Date Published: 01/04/2016 Desc: OPTIMAL HEALTH SYSTEMS NITRIC OXIDE TEST STRIPS
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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