# DFI CO., LTD. · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 388-25 Gomo-Ro , Jinrye-Myeon , Gimhae, Gyeongsangnam KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 01/04/2016 _(verified: appears in the quote below)_
- **Product code:** 75 M - - XA System, Test, Breath Nitric Oxide | 91 M - - IG Strip, Test Isoniazid _(verified: each item appears in the quote below)_
- **Product:** OPTIMAL HEALTH SYSTEMS NITRIC OXIDE TEST STRIPS | OPTIMAL HEALTH SYSTEMS NITRIC OXIDE TEST STRIPS _(verified: each item appears in the quote below)_

## 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

## 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

Source: https://www.accessdata.fda.gov/cms_ia/importalert_244.html

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).