DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107
FDA 510(k) clearance K060502 · decided 2006-05-18
Clearance details
- K-number
- K060502
- Device name
- DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107
- Applicant
- Dade Behring, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-02-24
- Decision date
- 2006-05-18
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- MLM
- Device class
- 2
- Regulation number
- 862.1678
- 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 |
|---|---|---|
| Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product recall (Z-1924-2013) | Siemens Healthcare Diagnostics, Inc. | 2013-08-07 |
| Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used recall (Z-0957-2013) | Siemens Healthcare Diagnostics, Inc. | 2013-03-15 |
| Dimension Tacrolimus Flex Reagent Cartridge, manufactured by Siemens Healthcare Diagnostic recall (Z-2407-2010) | Siemens Healthcare Diagnostics, Inc. | 2010-09-13 |
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 |