DFI Co., Ltd.
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 4
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2087-2026 | Class II | One Step K in vitro diagnostic test REF: 81A4 | April 2, 2026 |
| Z-2082-2026 | Class II | One Step 10A in vitro diagnostic test | April 2, 2026 |
| Z-2083-2026 | Class II | One Step UTI in vitro diagnostic test REF: 3374 | April 2, 2026 |
| Z-2086-2026 | Class II | Uric Acid in vitro diagnostic test REF: 31H0P | April 2, 2026 |
| Z-2084-2026 | Class II | One Step pH in vitro diagnostic test REF: 31I4P | April 2, 2026 |
| Z-2085-2026 | Class II | QUCARE Total Cholesterol in vitro diagnostic test REF: 6407 | April 2, 2026 |
| Z-2088-2026 | Class II | One Step P in vitro diagnostic test REF: 8194 | April 2, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K181024 | DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips | May 23, 2018 |
| K171521 | DUS R-50S (Urine Chemistry system) | February 16, 2018 |
| K102188 | CYBOW READER, MODELS 300 & 720 | August 9, 2011 |
| K052525 | CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS | March 29, 2006 |