IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE
FDA 510(k) clearance K093861 · decided 2010-02-05
Clearance details
- K-number
- K093861
- Device name
- IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE
- Applicant
- Iris International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-12-16
- Decision date
- 2010-02-05
- Days to decision
- 51 days
- Clearance type
- Special
- Product code
- LKM
- Device class
- 2
- Regulation number
- 864.5200
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Chatsworth, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345 recall (Z-1596-2023) | Beckman Coulter, Inc. | 2023-05-17 |
| DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, recall (Z-1597-2023) | Beckman Coulter, Inc. | 2023-05-17 |
| DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device recall (Z-1598-2023) | Beckman Coulter, Inc. | 2023-05-17 |
| UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis recall (Z-1599-2023) | Beckman Coulter, Inc. | 2023-05-17 |