DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108
FDA 510(k) clearance K081992 · decided 2008-08-05
Clearance details
- K-number
- K081992
- Device name
- DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-07-14
- Decision date
- 2008-08-05
- Days to decision
- 22 days
- Clearance type
- Special
- Product code
- MKW
- Device class
- 2
- Regulation number
- 862.1235
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| ARCHITECT CYCLOSPORINE (K080751) | Fujirebio Diagnostics,Inc. | 2008-09-11 |
| ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR (K071455) | Siemens Medical Solutions Diagnostics | 2008-09-11 |
| 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
No recalls on record reference this clearance.
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| ADVIA Centaur® AFP Immunoassay; Atellica IM Alpha Fetoprotein (AFP) (P930036/S025) | Siemens Healthcare Diagnostics, Inc. | 2025-07-16 |