DFI Co., Ltd.
DFI Co., Ltd. holds FDA 510(k) medical device clearances, first cleared 2006, most recent 2018, with 7 FDA device recalls on record.
Top product codes for DFI Co., Ltd.
FDA recalls by DFI Co., Ltd.
- Z-2087-2026 — One Step K in vitro diagnostic test REF: 81A4
- Z-2086-2026 — Uric Acid in vitro diagnostic test REF: 31H0P
- Z-2085-2026 — QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
- Z-2088-2026 — One Step P in vitro diagnostic test REF: 8194
- Z-2084-2026 — One Step pH in vitro diagnostic test REF: 31I4P
- Z-2082-2026 — One Step 10A in vitro diagnostic test
- Z-2083-2026 — One Step UTI in vitro diagnostic test REF: 3374
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by DFI Co., Ltd.
Data sourced from openFDA. This site is unofficial and independent of the FDA.