DFI Co., Ltd.
Medical device manufacturer in Jillye-Myeon.
4510(k) clearances
0PMA approvals
7recalls
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K181024 | DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsJIL · Traditional | 05/23/2018SE |
| K171521 | DUS R-50S (Urine Chemistry system)JIL · Traditional | 02/16/2018SE |
| K102188 | Cybow Reader, Models 300 & 720KQO · Traditional | 08/09/2011SE |
| K052525 | Cybow 11 Series Reagent Strips for UrinalysisJIL · Traditional | 03/29/2006SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2088-2026 Class II | One Step P in vitro diagnostic test REF: 8194The devices were distributed without required FDA premarket clearance or approval. | 04/02/2026Open, Classified |
| Z-2087-2026 Class II | One Step K in vitro diagnostic test REF: 81A4The devices were distributed without required FDA premarket clearance or approval. | 04/02/2026Open, Classified |
| Z-2086-2026 Class II | Uric Acid in vitro diagnostic test REF: 31H0PThe devices were distributed without required FDA premarket clearance or approval. | 04/02/2026Open, Classified |
| Z-2085-2026 Class II | QUCARE Total Cholesterol in vitro diagnostic test REF: 6407The devices were distributed without required FDA premarket clearance or approval. | 04/02/2026Open, Classified |
| Z-2084-2026 Class II | One Step pH in vitro diagnostic test REF: 31I4PThe devices were distributed without required FDA premarket clearance or approval. | 04/02/2026Open, Classified |
| Z-2083-2026 Class II | One Step UTI in vitro diagnostic test REF: 3374The devices were distributed without required FDA premarket clearance or approval. | 04/02/2026Open, Classified |
| Z-2082-2026 Class II | One Step 10A in vitro diagnostic testThe devices were distributed without required FDA premarket clearance or approval. | 04/02/2026Open, Classified |