Data / Medical devices / South Korea / Dfi Co., Ltd.
Dfi Co., Ltd.: FDA-registered device maker in Gimhae Jeonnam, South Korea, 1 510(k) clearance
Dfi Co., Ltd. is registered with the FDA (registration 3005841640) in Gimhae Jeonnam, South Korea. It lists 10 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 29, 2006. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005841640
- Address
- 388-25 Gomo-Ro Jillye-Myeon, Gimhae Jeonnam, South Korea, 50875
- Owner or operator
- DFI CO., LTD. (9089171)
- Roles
- Manufacturer
- First device listed
- June 28, 2006
- Registered through
- 2027
- Brand names listed
- QTEST 11
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | 1 | Manufacturer | accessdata.fda.gov |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | 1 | Manufacturer | accessdata.fda.gov |
| Blood, Occult, Colorimetric, In Urine | JIO | 2 | Manufacturer | accessdata.fda.gov |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | 1 | Manufacturer | accessdata.fda.gov |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | 1 | Manufacturer | accessdata.fda.gov |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | 1 | Manufacturer | accessdata.fda.gov |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | 1 | Manufacturer | accessdata.fda.gov |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | 2 | Manufacturer | accessdata.fda.gov |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | 1 | Manufacturer | accessdata.fda.gov |
| Test, Urine Leukocyte | LJX | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 29, 2006 | K052525 | CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS | JIL | Substantially Equivalent | DFI Co., Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 2, 2026 | 98739 | Class II | Ongoing | One Step 10A in vitro diagnostic test | The devices were distributed without required FDA premarket clearance or approval. | accessdata.fda.gov |
Compare with other makers
- All makers of Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
- All makers of Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- All makers of Test, Urine Leukocyte
- All makers of Nitroprusside, Ketones (Urinary, Non-Quant.)
- All makers of Dye-Indicator, Ph (Urinary, Non-Quantitative)
- All makers of Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
Updated May 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.