DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110
FDA 510(k) clearance K061838 · decided 2006-08-21
Clearance details
- K-number
- K061838
- Device name
- DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110
- Applicant
- Dade Behring, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-06-29
- Decision date
- 2006-08-21
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- JIX
- Device class
- 2
- Regulation number
- 862.1150
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Siemens Dimension Vista CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic p recall (Z-2720-2014) | Siemens Healthcare Diagnostics, Inc. | 2014-09-30 |
| Dimension Vista System CHEM 1 CAL, Catalog Number KC110, Lot Number 9DM001 The Dimension V recall (Z-0864-2010) | Siemens Healthcare Diagnostics, Inc. | 2010-02-26 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COBAS INTEGRA 400 PLUS CYCLOSPORINE (P920031/S003) | Dade Behring, Inc. | 2002-07-24 |
| COBAS INTEGRA CYCLOSPORINE (P920031/S002) | Dade Behring, Inc. | 2002-02-26 |
| EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031/S001) | Dade Behring, Inc. | 2000-08-11 |
| EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031) | Dade Behring, Inc. | 1996-10-02 |