Company ยท KR
DFI Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2018. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
7recalls (7 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 3 |
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 1 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 1 |
| KQO | Automated Urinalysis System | 1 |
| LJX | Test, Urine Leukocyte | 1 |
| MVO | Kit, Test, Multiple, Drugs Of Abuse, Over The Counter | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 23, 2018 | K181024 | DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips DFI Co., Ltd., KR | JIL |
| Feb 16, 2018 | K171521 | DUS R-50S (Urine Chemistry system) DFI Co., Ltd., KR | JIL |
| Aug 9, 2011 | K102188 | CYBOW READER, MODELS 300 & 720 DFI Co., Ltd., KR | KQO |
| Mar 29, 2006 | K052525 | CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS DFI Co., Ltd. | JIL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2026 | DFI Co., Ltd. One Step P in vitro diagnostic test
REF: 8194 Open, Classified |
JIR | None listed |
| May 6, 2026 | DFI Co., Ltd. One Step K in vitro diagnostic test
REF: 81A4 Open, Classified |
JIN | None listed |
| May 6, 2026 | DFI Co., Ltd. Uric Acid in vitro diagnostic test
REF: 31H0P Open, Classified |
KNK | None listed |
| May 6, 2026 | DFI Co., Ltd. QUCARE Total Cholesterol in vitro diagnostic test
REF: 6407 Open, Classified |
CHH | None listed |
| May 6, 2026 | DFI Co., Ltd. One Step pH in vitro diagnostic test
REF: 31I4P Open, Classified |
CEN | None listed |
| May 6, 2026 | DFI Co., Ltd. One Step UTI in vitro diagnostic test
REF: 3374 Open, Classified |
LJX | None listed |
| May 6, 2026 | DFI Co., Ltd. One Step 10A in vitro diagnostic test Open, Classified |
MVO | None listed |