DIMENSION VISTA FLEX REAGENT CARTRIDGES
FDA 510(k) clearance K061655 · decided 2006-07-10
Clearance details
- K-number
- K061655
- Device name
- DIMENSION VISTA FLEX REAGENT CARTRIDGES
- Applicant
- Dade Behring, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-06-13
- Decision date
- 2006-07-10
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- LDP
- Device class
- 2
- Regulation number
- 862.3030
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. F recall (Z-0339-2016) | Siemens Healthcare Diagnostics, Inc. | 2015-11-25 |
| Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the q recall (Z-2175-2012) | Siemens Healthcare Diagnostics, Inc. | 2012-08-09 |
| Dimension Vista(R) MG Flex(R) Reagent Cartridge The Dimension Vista(R) MG method is an in recall (Z-1433-2012) | Siemens Healthcare Diagnostics, Inc. | 2012-04-17 |
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 |