CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT
FDA 510(k) clearance K101852 · decided 2011-03-23
Clearance details
- K-number
- K101852
- Device name
- CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT
- Applicant
- Iris International Inc., A Division of Iris Iris I
- Decision
- Substantially Equivalent
- Date received
- 2010-07-01
- Decision date
- 2011-03-23
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- KQO
- Device class
- 1
- Regulation number
- 862.2900
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Chatsworth, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| iChemVELOCITY Urine Chemistry System- recall (Z-1944-2020) | Beckman Coulter Inc. | 2020-05-09 |
| iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY recall (Z-1894-2018) | Beckman Coulter Inc. | 2018-04-27 |
| iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, recall (Z-1384-2017) | Beckman Coulter Inc. | 2017-03-01 |
| iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080 recall (Z-2441-2015) | Iris Diagnostics | 2015-08-21 |