DFI CO., LTD. · 89-08 · KOREA (THE REPUBLIC OF)

For DFI CO., LTD., import alert is 89-08; country is KOREA (THE REPUBLIC OF); 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 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 listed twice: 388-25 Gomo-Ro , Jinrye-Myeon , Gimhae, Gyeongsangnam KOREA (THE REPUBLIC OF) and 388-25 Gomo-Ro , Jillye-Myeon , Gimhae, Gyeongsangnam KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.

What the source says

DFI CO., LTD. Date Published : 01/04/2016 388-25 Gomo-Ro , Jinrye-Myeon , Gimhae, Gyeongsangnam KOREA (THE REPUBLIC OF)

— 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.

— all from 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)

— accessdata.fda.gov, retrieved 2026-09-15

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.