| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| LKM | Counter, Urine Particle | Class II | Hematology | 1 | 2024-05-03 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | Class II | Clinical Chemistry | 1 | 2023-04-13 |
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | Class II | General, Plastic Surgery | 1 | 2022-10-17 |
| PZI | Prescription Use Blood Glucose Meter For Near-Patient Testing | Class II | Clinical Chemistry | 1 | 2022-05-23 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-05-03 | K232416 | AUTION EYE AI-4510 Urine Particle Analysis System | LKM | Class II | Hematology |
| 2023-04-13 | K193514 | AUTION MAX AX-4060 Urinalysis System | JIL | Class II | Clinical Chemistry |
| 2022-10-17 | K221175 | Multi-Lancet Device 2, ReliOn Premier Lancing Device | QRL | Class II | General, Plastic Surgery |
| 2022-05-23 | K200788 | Assure Titanium Blood Glucose Monitoring System | PZI | Class II | Clinical Chemistry |