DFI Co., Ltd.
Gimhae Jeonnam, KR
DFI CO., LTD. appears in FDA device records in Gimhae Jeonnam, KR. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005841640 | 3005841640 | DFI CO., LTD. | 388-25 Gomo-Ro, Gimhae Jeonnam 50875 KR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
- JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
- JIOBlood, Occult, Colorimetric, In Urine
- JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- LJXTest, Urine Leukocyte
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2088-2026 | One Step P in vitro diagnostic test REF: 8194 | The devices were distributed without required FDA premarket clearance or approval. | Class II | Open, Classified | |
| Z-2087-2026 | One Step K in vitro diagnostic test REF: 81A4 | The devices were distributed without required FDA premarket clearance or approval. | Class II | Open, Classified | |
| Z-2086-2026 | Uric Acid in vitro diagnostic test REF: 31H0P | The devices were distributed without required FDA premarket clearance or approval. | Class II | Open, Classified | |
| Z-2085-2026 | QUCARE Total Cholesterol in vitro diagnostic test REF: 6407 | The devices were distributed without required FDA premarket clearance or approval. | Class II | Open, Classified | |
| Z-2084-2026 | One Step pH in vitro diagnostic test REF: 31I4P | The devices were distributed without required FDA premarket clearance or approval. | Class II | Open, Classified | |
| Z-2083-2026 | One Step UTI in vitro diagnostic test REF: 3374 | The devices were distributed without required FDA premarket clearance or approval. | Class II | Open, Classified | |
| Z-2082-2026 | One Step 10A in vitro diagnostic test | The devices were distributed without required FDA premarket clearance or approval. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain