ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR
FDA 510(k) clearance K071455 · decided 2008-09-11
Clearance details
- K-number
- K071455
- Device name
- ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR
- Applicant
- Siemens Medical Solutions Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2007-05-25
- Decision date
- 2008-09-11
- Days to decision
- 475 days
- Clearance type
- Traditional
- Product code
- MKW
- Device class
- 2
- Regulation number
- 862.1235
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Tarrytown, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CYCLOSPORINE (K080751) | Fujirebio Diagnostics,Inc. | 2008-09-11 |
| DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108 (K081992) | Siemens Healthcare Diagnostics, Inc. | 2008-08-05 |
| DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE (K062236) | Dade Behring, Inc. | 2006-08-21 |
| EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (K053061) | Dade Behring, Inc. | 2006-02-06 |
| CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108 (K052017) | Dade Behring, Inc. | 2005-09-01 |
| AXSYM CYCLOSPORINE (K040761) | Abbott Laboratories, Inc. | 2004-04-30 |
| CEDIA CYCLOSPORINE PLUS ASSAY (K023208) | Microgenics Corp. | 2002-10-24 |
| CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE (K023065) | Dade Behring, Inc. | 2002-10-16 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ADVIA Centaur Cyclosporine recall (Z-1687-2018) | Siemens Healthcare Diagnostics, Inc. | 2018-05-04 |