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DFI Co., Ltd.

7 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
One Step 10A in vitro diagnostic test recall (Z-2082-2026)DFI Co., Ltd.2026-05-06
One Step UTI in vitro diagnostic test REF: 3374 recall (Z-2083-2026)DFI Co., Ltd.2026-05-06
One Step pH in vitro diagnostic test REF: 31I4P recall (Z-2084-2026)DFI Co., Ltd.2026-05-06
QUCARE Total Cholesterol in vitro diagnostic test REF: 6407 recall (Z-2085-2026)DFI Co., Ltd.2026-05-06
Uric Acid in vitro diagnostic test REF: 31H0P recall (Z-2086-2026)DFI Co., Ltd.2026-05-06
One Step K in vitro diagnostic test REF: 81A4 recall (Z-2087-2026)DFI Co., Ltd.2026-05-06
One Step P in vitro diagnostic test REF: 8194 recall (Z-2088-2026)DFI Co., Ltd.2026-05-06

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Every clearance here is in the API, with alerts when new ones post.